BioSkin LLC FDA Filings

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2024235	3000210483	BioSkin LLC	1	N	2026-01-01	240 E Hersey St Ste 2 ASHLAND OR US 97520
2027062	2027062	BIOSEAL	1	N	2026-01-01	167 WEST ORANGETHORPE AVE. PLACENTIA CA US 92870
2085402	1000519735	BIOSYS LABORATORIES, INC.	1	Y	2026-01-01	526 Mission Street S Pasadena CA US 91030
2242547	2242547	BIOSEARCH MEDICAL PRODUCTS, INC.	1	N	2026-01-01	4715 CORPORATE DR. NW SUITE 200 Concord NC US 28027
9615728	3002808761	BIOSPHERE MEDICAL, S.A.	1	N	2026-01-01	Parc des Nations - Paris Nord 2, 383 rue de la Belle Etoile 95700 ROISSY-EN-FRANCE, FRANCE Roissy Val-d'Oise FR 95700
9673241	3003248396	BIOSENSE WEBSTER, INC.	1	N	2026-01-01	CIRCUITO INTERIOR NORTE, No. 1820 PARQUE INDUSTRIAL SALVARCAR JUAREZ Chihuahua MX 32574
1000560772	1000560772	BIOSCULPTOR CORPORATION	1	N	2026-01-01	2480 W 82nd St Unit 1 Hialeah FL US 33016
3002945499	3002945499	BIOSIGMA SPA	1	N	2026-01-01	Via Valletta, 6 Cantarana di Cona (VE) Veneto IT 30010
3003193933	3003193933	BIOSPACE INC.	1	Y	2026-01-01	13850 CERRITOS CORPORATE DR STE C Cerritos CA US 90703
3008203003	3008203003	Biosense Webster (Israel), Ltd.	1	N	2026-01-01	4 Hatnufa Street Yokneam Northern IL 2066717
3010331770	3010331770	BIOSENSICS	1	N	2026-01-01	57 Chapel Street, Suite 200 Newton MA US 02458
3010872290	3010872290	Biosonic Technologies, LLC	1	N	2026-01-01	6370 Annie Oakley Drive Las Vegas NV US 89120
3013300026	3013300026	BIOSENSE WEBSTER, INC.	1	Y	2026-01-01	31 Technology Drive, Suite 200 -- Irvine CA US 92618
3014027738	3014027738	BIOSERENITY MEDICAL DEVICES GROUP	1	N	2026-01-01	6/8 rue Jean Antoine de Baif PARIS CEDEX 13 Ile-de-France FR 75013
3014654360	3014654360	BIOSAFE SUPPLIES, LLC	1	N	2026-01-01	230 Sunport Ln Ste 100 Orlando FL US 32809
3016057799	3016057799	BIOSCI INC.	1	Y	2026-01-01	23 Orchard Rd Ste 202 Skillman NJ US 08558
3018187017	3018187017	BIOSYNCHRONICITY CORPORATION	1	N	2026-01-01	325 118th Avenue SE, Ste 210 Bellevue WA US 98005
3022451073	3022451073	BIOSENSE WEBSTER, INC.	1	N	2026-01-01	23 Hubble Drive Irvine CA US 92618
3027241828	3027241828	BIOSERVO AB	1	N	2026-01-01	Torshamnsgatan 35 Kista Stockholm SE 16440
3029927676	3029927676	BIOSKIN AESTHETICS INC.	1	Y	2026-01-01	3100 Nw 2nd Ave Ste 407 Boca Raton FL US 33431
3033273230	3033273230	BIOS	1	N	2026-01-01	1295 Nesbit Drive Nesbit MS US 38651
3034246205	3034246205	BIOSQUARE Inc.	1	N	2026-01-01	15, Samsung 1-ro 4-gil Hwaseong-si Gyeonggi KR 18449
3043620414	3043620414	Bioseal	1	N	2026-01-01	801 Industrial Blvd Ste 100 Grapevine TX US 76051
1419300	1419300	BIOSYNERGY, INC.	1	N	2020-04-25	1940 E Devon Ave ELK GROVE VILLAGE IL US 60007
2020638	2020638	BIOSENSE WEBSTER, INC.	1	Y	2020-04-25	5110 COMMERCE RD. BALDWIN PARK CA US 91706

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
58742	1452071458	P990071	STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR	LPB	2000-05-31
58745	1452071458	P990071	STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR	LPB	2000-05-31
308348	1452071458	P990071	STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR	LPB	2000-05-31
58742	1419020728	P990025	NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER	DRF	2000-06-15
58745	1419020728	P990025	NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER	DRF	2000-06-15
308348	1419020728	P990025	NAVI-STAR DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER	DRF	2000-06-15
58742	1559194504	P950005	WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER	LPB	1997-09-30
58745	1559194504	P950005	WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER	LPB	1997-09-30
308348	1559194504	P950005	WEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER	LPB	1997-09-30
58745	1163060217	P240006	VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump)	QZI	2024-11-06
308348	1163060217	P240006	VARIPULSE™ Platform (VARIPULSE™ Catheter; TRUPULSE™ Generator; Sterile Interface Cable; nGEN™ Pump)	QZI	2024-11-06
58745	1316897506	P210027	QDOT MICRO™ System	OAE	2022-11-23
308348	1316897506	P210027	QDOT MICRO™ System	OAE	2022-11-23
58742	1165329946	P040036	NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER	LPB	2006-08-11
58745	1165329946	P040036	NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER	LPB	2006-08-11
308348	1165329946	P040036	NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER	LPB	2006-08-11
58742	1612366345	P030031	BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS	OAD	2004-11-05
58745	1612366345	P030031	BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS	OAD	2004-11-05
308348	1612366345	P030031	BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS	OAD	2004-11-05
58742	1366746373	P010068	NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER	OAD	2002-09-27
58745	1366746373	P010068	NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER	OAD	2002-09-27
308348	1366746373	P010068	NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER	OAD	2002-09-27
58742	1148648591	K992965	CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085	DRF	1999-11-26
58745	1148648591	K992965	CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085	DRF	1999-11-26
308348	1148648591	K992965	CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085	DRF	1999-11-26
58742	1367532919	K991531	CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078	DRF	1999-10-04
58745	1367532919	K991531	CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078	DRF	1999-10-04
308348	1367532919	K991531	CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078	DRF	1999-10-04
58745	1780546532	K982740	CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813S	DYB	1998-08-28
308348	1780546532	K982740	CORDIS WEBSTER PREFACE BRAIDED GUIDING SHEATH & PERRY EXCHANGE DILATOR, MODEL #'S 301-803A, 301-803P, 301-803M, 301-813S	DYB	1998-08-28
222817	1310024945	K982541	VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608	FMI	1998-10-28
58742	1063935976	K982415	CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210	DRF	1998-08-10
58745	1063935976	K982415	CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210	DRF	1998-08-10
308348	1063935976	K982415	CORDIS WEBSTER REF-STAR EXTERNAL REFERENCE PATCH, MODEL # D-1210	DRF	1998-08-10
58742	1078027235	K980961	CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04.	DRF	1998-05-28
58745	1078027235	K980961	CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04.	DRF	1998-05-28
308348	1078027235	K980961	CORDIS WEBSTER REF-STAR EX SURFACE REFERENCE DEVICE MODEL'S D-1204-01, -02,-03, AND -04.	DRF	1998-05-28
58742	1942304381	K970264	CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM	DYB	1997-10-28
58745	1942304381	K970264	CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM	DYB	1997-10-28
308348	1942304381	K970264	CORDIS WEBSTER BRAIDED GUIDING SHEATH EXCHANGE SYSTEM	DYB	1997-10-28
222817	1362394313	K960250	VACUTAINER BRAND PLUS SERUM & SST TUBES	JKA	1996-03-29
58742	1425029505	K955817	CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETER	DRF	1996-03-25
58745	1425029505	K955817	CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETER	DRF	1996-03-25
308348	1425029505	K955817	CORIDIS WEBSTER DEFLECTABLE BRAIDED-TIP ELECTRODE CATHETER	DRF	1996-03-25
58742	1816500739	K954390	CORDIS WESTER STAR CATHETER	DRF	1995-12-21
58745	1816500739	K954390	CORDIS WESTER STAR CATHETER	DRF	1995-12-21
308348	1816500739	K954390	CORDIS WESTER STAR CATHETER	DRF	1995-12-21
58742	1079815869	K953768	CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETER	DRF	1995-11-22
58745	1079815869	K953768	CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETER	DRF	1995-11-22
308348	1079815869	K953768	CORDIS WEBSTER A20 DIAGNOSTIC DEFLECTABLE TIP CATHETER	DRF	1995-11-22
58742	1700098476	K953663	CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETER	DRF	1996-09-18
58745	1700098476	K953663	CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETER	DRF	1996-09-18
308348	1700098476	K953663	CORDIS WEBSTER T20 DIAGNOSTIC DEFLECTABLE TIP CATHETER	DRF	1996-09-18
34742	1117764780	K893814	SURGICAL INSTRUMENT KIT, DISPOSABLE	LRO	1989-08-10
58742	1306939737	K892265
58745	1306939737	K892265
308348	1306939737	K892265
34742	1309471349	K882712	STICK SPONGE	EFQ	1988-08-03
34742	1957424290	K882708	GAUZE SPONGE, X-RAY DETECTABLE	GDY	1988-08-03
34742	1205351986	K882707	GAUZE PACKING, X-RAY DETECTABLE	GDY	1988-08-03
34742	1529164951	K882696	DERMICEL, MONTGOMERY STRAP	NAD	1988-08-26
34742	1332126698	K882695	RUBBER BAND, STERILE	ECI	1988-10-13
34742	1059067784	K882694	FIXATION DEVICE, TRACH TUBE	CBH	1988-08-15
58742	1718281991	K853383	CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN	DYG	1985-12-03
58745	1718281991	K853383	CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN	DYG	1985-12-03
308348	1718281991	K853383	CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN	DYG	1985-12-03
58742	1373562806	K841802	ELECTRODE CATHETER, ORTHOGONAL TYPE	LDF	1984-10-18
58745	1373562806	K841802	ELECTRODE CATHETER, ORTHOGONAL TYPE	LDF	1984-10-18
58742	1836872792	K834602	SWITCHING UNIT ELECTRODE CATHETER	DRF	1984-05-09
58745	1836872792	K834602	SWITCHING UNIT ELECTRODE CATHETER	DRF	1984-05-09
308348	1836872792	K834602	SWITCHING UNIT ELECTRODE CATHETER	DRF	1984-05-09
31195	1043478316	K833904	TEMPTREND II	KPD	1983-12-27
31195	1144676174	K821312	TEMPTREND TEMPERATURE TREND INDICATOR	KPD	1982-05-28
31195	1525547432	K802319	HEMOTEMP TM	KSE	1980-10-10
112859	1526307804	K254085	CARTO™ 3 EP Navigation System V9.0 with PIU Plus	DQK	2026-01-18
308348	1526307804	K254085	CARTO™ 3 EP Navigation System V9.0 with PIU Plus	DQK	2026-01-18
112859	1196703283	K252972	CARTO™ 3 EP Navigation System V8.4	DQK	2026-02-20
308348	1196703283	K252972	CARTO™ 3 EP Navigation System V8.4	DQK	2026-02-20
314019	1196703283	K252972	CARTO™ 3 EP Navigation System V8.4	DQK	2026-02-20
112859	1889108606	K252302	CARTO™ 3 EP Navigation System V8.1	DQK	2025-08-22
308348	1889108606	K252302	CARTO™ 3 EP Navigation System V8.1	DQK	2025-08-22
314019	1889108606	K252302	CARTO™ 3 EP Navigation System V8.1	DQK	2025-08-22
324011	1491525407	K243788	IceCap product line	GXY	2025-03-13
58745	1999568673	K241540	NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter	OBJ	2024-06-28
308348	1999568673	K241540	NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter	OBJ	2024-06-28
308348	2045780395	K240050	SOUNDSTAR™ CRYSTAL Ultrasound Catheter	OBJ	2024-06-12
58745	1570366164	K231312	PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID	MTD	2023-07-10
308348	1570366164	K231312	PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID	MTD	2023-07-10
112859	1259048607	K231207	CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)	DQK	2023-09-07
308348	1259048607	K231207	CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)	DQK	2023-09-07
314019	1259048607	K231207	CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)	DQK	2023-09-07
58745	1838273211	K230253	OPTRELL™ Mapping Catheter with TRUEref™ Technology	MTD	2023-03-02
308348	1838273211	K230253	OPTRELL™ Mapping Catheter with TRUEref™ Technology	MTD	2023-03-02
58745	2007244677	K223766	NUVISION™ NAV Ultrasound Catheter	OBJ	2023-02-16
308348	2007244677	K223766	NUVISION™ NAV Ultrasound Catheter	OBJ	2023-02-16
112859	1886013154	K223733	CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4	DQK	2023-02-16
308348	1886013154	K223733	CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4	DQK	2023-02-16
112859	1298566348	K221112	CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)	DQK	2022-08-17
308348	1298566348	K221112	CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)	DQK	2022-08-17
314019	1298566348	K221112	CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)	DQK	2022-08-17
112859	1446518845	K213264	CARTO 3 EP Navigation System Version 7.2	DQK	2021-10-29
308348	1446518845	K213264	CARTO 3 EP Navigation System Version 7.2	DQK	2021-10-29

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
DRF	98	2022-01-26
DQK	49	2026-02-20
MTD	19	2023-07-10
OBJ	14	2024-06-28
DYB	11	2017-07-25
LPB	11	2006-08-11
KRD	8	2019-11-21
OAD	8	2004-11-05
DSA	4	2000-07-21
DYG	4	1985-12-03
LDF	3	1984-10-18
FMF	2	2018-05-10
MNW	2	2014-09-23
GDY	2	1988-08-03
KPD	2	1983-12-27
GXY	1	2025-03-13
NOY	1	2017-06-21
PGW	1	2016-10-24
NFO	1	2014-04-30
DXN	1	2013-09-04
OAN	1	2009-01-27
DQO	1	2006-08-09
DQX	1	2006-06-02
NAJ	1	2002-11-22
HCG	1	2001-06-21
FMI	1	1998-10-28
JKA	1	1996-03-29
LRO	1	1989-08-10
ECI	1	1988-10-13
NAD	1	1988-08-26
CBH	1	1988-08-15
EFQ	1	1988-08-03
KSE	1	1980-10-10

NDC#

BIOSAVIA External Analgesic Pain Relief
BIOSAVIA USA, LLC
CAPSAICIN

PMA#

QDOT MICRO™ System
2022-11-23
Biosense Webster, Inc.31 Technology Drive, Suite 200irvine, CA 92618 PMA NumberP210027 Date Received07/06/2021 Decision Date11/23/2022 Product Codes OAD OAE Advisory Committee Cardiovascular Clinical TrialsNCT03775512 Expedited Review Granted? No
Biosense Webster Cables
2022-09-30
BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP990071 Supplement NumberS056 Date Received09/02/2022 Decision Date09/30/2022 Product Code LPB Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Pro...
Celsius FLTRR, EZ Steer Nav DS Catheter
2022-09-30
BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP010068 Supplement NumberS070 Date Received09/02/2022 Decision Date09/30/2022 Product Code OAD Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Pro...
Celsius RMT ThermoCool Cather, Celsius ThermoCool Cather, EZ Steer ThermoCool Catheter, EZ Steer ThermoCool NAV Catheter
2022-09-30
BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP030031 Supplement NumberS128 Date Received09/02/2022 Decision Date09/30/2022 Product Code OAD Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Pro...
ThermoCool SmartTouch Catheters, NaviStar ThermoCool Catheter, NaviStar RMT ThermoCool Catheter, EZ Steer ThermoCool NAV
2022-09-30
BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP040036 Supplement NumberS090 Date Received09/02/2022 Decision Date09/30/2022 Product Code LPB Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Pro...
Celsius Catheter, Celsius RMT Catheter, Celsius FLTR, Deflectable Diagnostic/Ablation Catheter, EZ Steer Catheter, EZ St
2022-09-30
Biosense Webster, Inc31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP950005 Supplement NumberS085 Date Received09/02/2022 Decision Date09/30/2022 Product Code LPB Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Proc...
NaviStar RMT Catheter, NaviStar Catheter, EZ Steer NAV Catheter,
2022-09-30
BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP990025 Supplement NumberS070 Date Received09/02/2022 Decision Date09/30/2022 Product Code DRF Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Pro...
NAVISTAR
2022-09-09
BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP990025 Supplement NumberS069 Date Received06/10/2022 Decision Date09/09/2022 Product Code DRF Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Rea...
NAVISTAR THERMOCOOL, THERMOCOOL SMARTTOUCH (ST)
2022-09-09
BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP040036 Supplement NumberS089 Date Received06/10/2022 Decision Date09/09/2022 Product Code LPB Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Rea...
CELSIUS THERMOCOOL, NAVISTAR THERMOCOOL, THERMOCOOL EZ STEER, THERMOCOOL SF, THERMOCOOL SMARTTOUCH (ST), THERMOCOOL SMAR
2022-09-09
BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP030031 Supplement NumberS127 Date Received06/10/2022 Decision Date09/09/2022 Product Code OAD Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Rea...
CELSIUS
2022-09-09
Biosense Webster, Inc31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP950005 Supplement NumberS084 Date Received06/10/2022 Decision Date09/09/2022 Product Code LPB Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reas...
8mm Dual Sensor (DS) Catheters
2022-09-09
BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP010068 Supplement NumberS069 Date Received06/10/2022 Decision Date09/09/2022 Product Code OAD Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Rea...
SmartAblate Irrigation Tubing Set and nGEN Pump
2022-06-08
BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP990071 Supplement NumberS054 Date Received05/18/2022 Decision Date06/08/2022 Product Code LPB Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Pro...
BioFreedom Drug Coated Coronary Stent System
2022-04-14
Biosensors International USA, Inc.1013 Centre Rd.suite 228wilmington, DE 19805 PMA NumberP190020 Date Received08/16/2019 Decision Date04/14/2022 Product Code NIQ Advisory Committee Cardiovascular Clinical TrialsNCT02843633 Expedited Review Granted? No
SmartAblate Irrigation Tubing Set
2022-03-15
BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP990071 Supplement NumberS053 Date Received02/16/2022 Decision Date03/15/2022 Product Code LPB Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Pro...
ThermoCool SmartTouch
2022-02-01
BIOSENSE WEBSTER, INC.
ThermoCool SmartTouch SF
2022-02-01
BIOSENSE WEBSTER, INC.
Biosense Webster Cables, Celsius Catheter, Celsius FLTR, Deflectable Diagnostic/Ablation Catheter,EZ Steer Catheter, EZ
2021-09-22
Biosense Webster, Inc
Biosense Webster Cables
2021-09-22
BIOSENSE WEBSTER, INC.
Biosense Webster Cables, EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter
2021-09-22
BIOSENSE WEBSTER, INC.
Celsius RMT ThermoCool Catheter, Celsius ThermoCool Catheter, EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Cath
2021-09-22
BIOSENSE WEBSTER, INC.
EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Catheter, NaviStar RMT ThermoCool Catheter, NaviStar ThermoCool C
2021-09-22
BIOSENSE WEBSTER, INC.
Biosense Webster Cables, Celsius DS Catheter, Celsius FLTR, EZ Steer Nav DS Catheter, NaviStar DS Catheter, NaviStar RMT
2021-09-22
BIOSENSE WEBSTER, INC.
THERMOCOOL SMARTTOUCH® Uni-Directional Navigation Catheter, THERMOCOOL SMARTTOUCH® Bi-Directional Navigation Catheter
2021-09-07
BIOSENSE WEBSTER, INC.
THERMOCOOL SMARTTOUCH® Uni-Directional Navigation Catheter, THERMOCOOL SMARTTOUCH® Bi-Directional Navigation Catheter, T
2021-09-07
BIOSENSE WEBSTER, INC.
Celsius FLTR (Flutter) Catheter, Celsius Electrophysiology Catheter, Webster Electrophysiology Catheter EZ Steer DS Bi-D
2021-07-09
Biosense Webster, Inc
Smartablate System Interface Cables
2021-07-09
BIOSENSE WEBSTER, INC.
EZ Steer ThemoCool Nav Bi-Directional Electrophysiology Catheter, Navistar ThermoCool Catheter, Navistar RMT ThermoCool,
2021-07-09
BIOSENSE WEBSTER, INC.
Celsius ThermoCool Electrophysiology Catheter, EZ Steer ThermoCool Bi-Directional Electrophysiology Catheter, EZ Steer T
2021-07-09
BIOSENSE WEBSTER, INC.
Celsius FLTR (Flutter) Catheter, EZ STEER NAV Bi-Directional and EZ STEER NAV DS Bi-Directional Diagnostic/Ablation Defl
2021-07-09
BIOSENSE WEBSTER, INC.
Interface CABLES, Navistar Electrophysiology Catheter, EZ Steer Nav Bi-Directional Electrophysiology Catheter, Navistar
2021-07-09
BIOSENSE WEBSTER, INC.
THERMOCOOL SMARTTOUCH SF Catheter
2021-05-13
BIOSENSE WEBSTER, INC.
EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Catheter, NaviStar RMT ThermoCool Catheter, NaviStar ThermoCool Ca
2021-04-28
BIOSENSE WEBSTER, INC.
Celsius RMT ThermoCool Catheter, Celsius ThermoCool Catheter, EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Cath
2021-04-28
BIOSENSE WEBSTER, INC.
Biosense Webster Cables, Celsius Catheter, Celsius RMT Catheter, Celsius FLTR, Deflectable Diagnostic/Ablation Catheter,
2021-04-28
Biosense Webster, Inc
Biosense Webster Cables, EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter
2021-04-28
BIOSENSE WEBSTER, INC.
Biosense Webster Cables
2021-04-28
BIOSENSE WEBSTER, INC.
Biosense Webster Cables, Celsius DS Catheter, Celsius FLTR, EZ Steer Nav DS Catheter, NaviStar DS Catheter, NaviStar RMT
2021-04-28
BIOSENSE WEBSTER, INC.
EZ STEER™THERMOCOOL, THERMOCOOL™SF NAV, THERMOCOOL™SF
2021-04-27
BIOSENSE WEBSTER, INC.
CELSIUS™, CELSIUS™DS, CELSIUS™RMT, CELSIUS™THERMOCOOL, CELSIUS
2021-04-27
Biosense Webster, Inc

200 records. Showing 1-40. Next

PMN#

IceCap product line
2025-03-13
Bioserenity Medical Devices Group
Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)
2024-12-30
Bios S.R.L.
Bioscope Neuromonitor Device
2024-12-13
Biosys Biyomedikal Muhendislik San. VE Tic. A.S.
NUVISION? Ultrasound Catheter; NUVISION? NAV Ultrasound Catheter
2024-06-28
Biosense Webster, Inc.
Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)
2024-06-14
Bios S.R.L.
SOUNDSTAR? CRYSTAL Ultrasound Catheter
2024-06-12
Biosense Webster, Inc.
Neuronaute Plus
2023-11-09
Bioserenity Sas
NuEra Tight RF Model OptiStream
2023-10-30
Bios S.R.L.
CARTO? 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)
2023-09-07
Biosense Webster, Inc.
NuEra Tight RF Family
2023-08-11
Bios S.R.L.
CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S)
2023-07-10
Biosense Webster, Inc.
PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID
2023-07-10
Biosense Webster, Inc.
NuEra Tight RF Model APMD145.M70-US
2023-05-02
Bios S.R.L.
OPTRELL? Mapping Catheter with TRUEref? Technology
2023-03-02
Biosense Webster, Inc.
CARTO® 3 EP Navigation System with CARTOSOUND? 4D Version 7.4
2023-02-16
Biosense Webster, Inc.
NUVISION? NAV Ultrasound Catheter
2023-02-16
Biosense Webster, Inc.
Neuronaute with IceCap 2 & IceCap 2 Small
2023-01-12
Bioserenity
CARTO 3 EP Navigation System With Advanced Focus Mapping (AFM)
2022-08-17
Biosense Webster, Inc.
OPTRELL Mapping Catheter With TRUEref Technology
2022-03-18
Biosense Webster, Inc.
LASSOSTAR NAV Circular Mapping Catheter
2022-01-26
Biosense Webster, Inc.
CARTO 3 EP Navigation System Version 7.2
2021-10-29
Biosense Webster, Inc.
Si-Mochi
2021-04-21
Biostone Ltd
NuEra Tight RF, NuEra Tight RF Plus
2021-04-21
BIOS S.r.l.
NuEra Tight Family, EMS Model
2020-12-31
Bios S.r.l.
Neuronaute
2020-12-10
Bioserenity SAS
CARTO® 3 EP Navigation System With Signal Processing Unit
2020-11-25
Biosense Webster, Inc.
CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV
2020-09-09
BioSystems S.A.
NuEra Tight, NuEra Tight EMS
2020-08-11
Bios S.R.L.
Pentaray Nav Eco High-Density Mapping Catheter
2020-08-06
Biosense Webster, Inc
Carto Octaray Mapping Catheter With Trueref Technology
2020-07-31
Biosense Webster, Inc.
LassoStar Circular Mapping Catheter
2020-06-30
Biosense Webster, Inc.
Transferrin
2020-03-16
BioSystems S.A.
TruDi Navigation System
2020-01-30
Biosense Webster
Torpedo Gelatin Foam
2019-11-21
Biosphere Medical, S.A.
Silicone Foley Catheter
2019-11-06
Biosensors International Pte Ltd
EmboCube Embolization Gelatin
2019-08-06
Biosphere Medical, S.A.
CARTO 3 EP Navigation System, Version 7.1 And Accessories
2019-07-20
Biosense Webster, Inc.
Torpedo Gelatin Foam
2019-06-18
Biosphere Medical, S.A.
Alpha-AMYLASE DIRECT, Alpha-AMYLASE EPS, Alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL
2019-05-02
BioSystems S.A.
EmboCube Embolization Gelatin
2018-09-27
Biosphere Medical, S.A.

200 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next