FDA.reportPublic FDA data

Amplatzer™ Talisman™

Primary DI
05415067033345
Brand
Amplatzer™ Talisman™
Company
ST. JUDE MEDICAL, INC.
Model
9-PFO-3525
Catalog number
9-PFO-3525
Device description
PFO Occluder
Published
2021-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MLVTranscatheter septal occluder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MLVTranscatheter Septal OccluderUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067033345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067033345054150670333455415067033345

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac occluderAn implantable disk-like device intended to be used for the minimally-invasive closure of cardiac defects and deployed using a dedicated delivery catheter/sheath. It is made of wire mesh [e.g., nickel-titanium alloy (Nitinol)], and possibly additional materials (e.g., polyester), and is typically self-expandable. The device is used to treat cardiac disorders that may include (but not limited to) atrial septal defect (ASD), ventricular septal defect (VSD), patent foramen ovale (PFO), or patent ductus arteriosus (PDA). Disposable devices dedicated to implantation may be included with the implant.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge9French
Outer Diameter35Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
149818952
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05414734509138NA3630W3630W2026-03-04
05415067056009Volt™K-VOLT-HDI-MK-VOLT-HDI-M2026-02-25
05415067056016Volt™K-VOLT-HDI-SK-VOLT-HDI-S2026-02-25
05415067056023Volt™K-VOLT-I-MK-VOLT-I-M2026-02-25
05415067056030Volt™K-VOLT-I-SK-VOLT-I-S2026-02-25
05415067055507Zenex MRI™PM1283PM12832026-01-22
05415067055514Zenex MRI™PM2283PM22832026-01-22
05415067036650Navitor™NVTR-LS-LGNVTR-LS-LG2023-01-16
05415067036667Navitor™NVTR-LS-SMNVTR-LS-SM2023-01-16
05415067055613EnSite™ENSITE-SW-06ENSITE-SW-062026-01-08
05415067051417Current™PFA-ECG-LNAMPFA-ECG-LNAM2026-01-06
05415067051516Current™PFA-GEN-01PFA-GEN-012026-01-06
05415067051554Current™PFA-ECG-CBLPFA-ECG-CBL2026-01-06
05415067051615Current™PFA-ECG-RNAMPFA-ECG-RNAM2026-01-06
05415067051721Current™PFA-GEN-CARTPFA-GEN-CART2026-01-06
05415067051752Current™PFA-R-GEN-01PFA-R-GEN-012026-01-06
05415067051813Current™GEN-3RD-RECGEN-3RD-REC2026-01-06
05415067052919Current™PFA-CIM-CBLPFA-CIM-CBL2026-01-06
05415067053022Volt™ PFA Sensor Enabled™A-VOLT-01A-VOLT-012026-01-06
05415067053886Current™PFA-GEN-V101PFA-GEN-V1012026-01-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415067033307Amplatzer™ Talisman™ST. JUDE MEDICAL, INC.MLV2021-09-29
05415067033314Amplatzer™ Talisman™ST. JUDE MEDICAL, INC.MLV2021-09-29
05415067033321Amplatzer™ Talisman™ST. JUDE MEDICAL, INC.MLV2021-09-29
00733132636525GORE CARDIOFORM ASD OccluderW. L. Gore & Associates, Inc.MLV2019-08-07
00733132636488GORE CARDIOFORM ASD OccluderW. L. Gore & Associates, Inc.MLV2019-07-03
00733132636495GORE CARDIOFORM ASD OccluderW. L. Gore & Associates, Inc.MLV2019-07-03
00733132636501GORE CARDIOFORM ASD OccluderW. L. Gore & Associates, Inc.MLV2019-07-03
00733132636518GORE CARDIOFORM ASD OccluderW. L. Gore & Associates, Inc.MLV2019-07-03
05415067028105Amplatzer™AGA MEDICAL CORPORATIONMLV2017-02-22
05415067028112Amplatzer™AGA MEDICAL CORPORATIONMLV2017-02-22
05415067028129Amplatzer™AGA MEDICAL CORPORATIONMLV2017-02-22
05415067028136Amplatzer™AGA MEDICAL CORPORATIONMLV2017-02-22
05415067028143Amplatzer™AGA MEDICAL CORPORATIONMLV2017-02-22
H373HX201533GORE HELEX Septal OccluderW. L. Gore & Associates, Inc.MLV2017-02-13
H373HX20203GORE HELEX Septal OccluderW. L. Gore & Associates, Inc.MLV2017-02-13
H373HX202534GORE HELEX Septal OccluderW. L. Gore & Associates, Inc.MLV2017-02-13
H373HX203030GORE HELEX Septal OccluderW. L. Gore & Associates, Inc.MLV2017-02-13
H373HX203535GORE HELEX Septal OccluderW. L. Gore & Associates, Inc.MLV2017-02-13
00733132617609Gore Septal OccluderW. L. Gore & Associates, Inc.MLV2017-02-13
00733132631001GORE CARDIOFORM Septal OccluderW. L. Gore & Associates, Inc.MLV2017-02-13
00733132631018GORE CARDIOFORM Septal OccluderW. L. Gore & Associates, Inc.MLV2017-02-13
00733132631025GORE CARDIOFORM Septal OccluderW. L. Gore & Associates, Inc.MLV2017-02-13
00733132631032GORE CARDIOFORM Septal OccluderW. L. Gore & Associates, Inc.MLV2017-02-13
00811806011271Amplatzer™ST. JUDE MEDICAL, INC.MLV2016-11-08
00811806011288Amplatzer™ST. JUDE MEDICAL, INC.MLV2016-11-08
00811806011301Amplatzer™ST. JUDE MEDICAL, INC.MLV2016-11-08
05415067019127AMPLATZER™AGA MEDICAL CORPORATIONMLV2015-01-27
05415067019134AMPLATZER™ AGA MEDICAL CORPORATIONMLV2015-01-27
05415067019141AMPLATZER™ AGA MEDICAL CORPORATIONMLV2015-01-27
05415067019158AMPLATZER™ AGA MEDICAL CORPORATIONMLV2015-01-27