THERAGENICS CORP.

Matched from indexed company URL: THERAGEN, LLC

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1037598	1037598	THERAGENICS CORP.	1	N	2026-01-01	5203 BRISTOL INDUSTRIAL WAY BUFORD GA US 30518
3011623145	3011623145	Theragenics Costa Rica Limitada	1	N	2026-01-01	Zona Franca El Coyol, Building B 13.3 El Coyol Alajuela CR 20113
3013378804	3013378804	THERAGEN, INC.	1	N	2026-01-01	10151 Deerwood Park Blvd. Jacksonville FL US 32256

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
201627	1325888683	P190030	ActaStim-S Spine Fusion Stimulator	LOF	2020-12-09
429	2061752021	K974118	WORLDWIDE MEDICAL TECHNOLOGIES SEED IMPLANT NEEDLE SET	IWJ	1998-01-23
197143	1678251487	K192195	Sterile Dilator	DRE	2019-09-26
197143	1665475832	K172487	Coaxial Dilator Set (Micro-Introducer)	DRE	2017-10-16
197143	1127760062	K123430	MICROSLIDER TEARAWAY INTRODUCER SET	DYB	2013-04-12
201627	1696634662	K112934	NEUROTECH RECOVERY	GXY	2012-01-20
201627	1636553972	K112258	NEUROTECH PLUS	GZJ	2012-01-09
429	1742953846	K111979	RADIOACTIVE SEED LOCALIZATION NEEDLE	KXK	2011-10-18
201627	1579610878	K110350	KNEEHAB XP	GZJ	2011-08-03
429	1740817715	K103319	I-SEED	KXK	2011-01-03
429	1075991080	K083274	WORLDWIDE MEDICAL TECHNOLOGIES ANCHOR MARKER, MARKER STRAND AND MARKER	KXK	2009-01-08
429	1910411391	K072296	POIINT OF CARE STRANDING SYSTEM, MODE 1004-00	KXK	2007-09-26
429	1941638970	K071550	PRE-WAXED NEEDLES WITH GOLD FIDUCIARY MARKERS	KXK	2007-07-18
197143	1700306330	K071330	GALTSTICK INTRODUCER SYSTEM	DRE	2007-10-31
429	2048734023	K060987	OSCERA7 SYNTHETIC ABSORBABLE BONE WAX, MODEL OS31	MTJ	2006-11-02
429	1356169062	K043596	THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06	KXK	2005-01-26
197143	1465743914	K043525	CATHETER INTRODUCER	DYB	2005-02-09
429	1067483360	K040339	BRACHYTHERAPY STRAND DEVICE	KXK	2004-04-08
429	1891315088	K034062	CP SLEEVE AND RIVER SLEEVE	KXK	2004-01-30
429	1914874985	K023179	READI-STRAND, MODEL PSSTRAND	KXK	2003-07-02
429	1684529436	K021343	ISOSEEDS I-125	KXK	2002-05-20
429	1980153791	K021311	SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL	KXK	2002-07-13
429	1948276853	K013975	CP-SLEEVE	KXK	2002-02-22
429	1456586898	K013964	MODIFICATION TO ACCU-SPACE PLAIN GUT ABSORBABLE SEEDING SPACERS	KXK	2002-01-24
429	1972275226	K011493	MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY	KPT	2002-10-01
429	1628942864	K010621	ACCU-SPACE ABSORBABLE SEEDING SPACERS	KXK	2001-09-04
429	1223928454	K010283	THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200	KXK	2001-04-26
197143	1855815254	K000737	COAXIAL DILATOR SET	DRE	2000-08-01
197143	1108758527	K000313	TEARAWAY INTRODUCER SHEATH	DYB	2000-06-16
197143	1067056713
429	2069650198

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
KXK	23	2011-10-18
DRE	4	2019-09-26
DYB	3	2013-04-12
GZJ	2	2012-01-09
IWJ	2	1998-01-23
LOF	1	2020-12-09
GXY	1	2012-01-20
MTJ	1	2006-11-02
KPT	1	2002-10-01

PMA#

ActaStim-S Spine Fusion Stimulator

2022-06-17

Theragen, Inc.11220 Assett Loopsuite 101manassas, VA 20109 PMA NumberP190030 Supplement NumberS001 Date Received04/08/2022 Decision Date06/17/2022 Product Code LOF Advisory Committee Orthopedic Supplement Typereal-time Process Supplement Reason Change Desi...