FDA.reportPublic FDA data

Amplatzer™

Primary DI
00811806011288
Brand
Amplatzer™
Company
ST. JUDE MEDICAL, INC.
Model
PFO Occluder
Catalog number
9-PFO-025
Published
2016-11-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
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
00811806011288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811806011288008118060112888118060112880811806011288

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac occluderA sterile, disk-like, device used for the non-surgical closure of cardiac defects. The device is typically self-expandable and made of wire mesh [e.g., nickel-titanium alloy (Nitinol)], and possibly additional materials (e.g., polyester). It is implanted using a dedicated catheter/sheath and delivery cable. The device is used to treat cardiac disorders that may include, but not limited to; an atrial septal defect (ASD), a ventricular septal defect (VSD), patent foramen ovale (PFO), or patent ductus arteriosus (PDA). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter25Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
149818952
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05415067053039Current™PFA-AMP-RETURN-CBLPFA-AMP-RETURN-CBL2026-08-03
05415067055002Current™PFA-TSQ-CBLPFA-TSQ-CBL2026-08-03
05415067055583Current™PFA-GEN-OVERLAY-FPFA-GEN-OVERLAY-F2026-08-03
05415067055897Current™PFA-GEN-V110PFA-GEN-V1102026-08-03
00811806011295Amplatzer™9-PFO-0309-PFO-0302026-07-31
05415067045447Epic™EMAX-21EMAX-212023-08-01
05415067045454Epic™EMAX-25EMAX-252023-08-01
05415067045461Epic™EMAX-19EMAX-192023-08-01
05415067045478Epic™EMAX-23EMAX-232023-08-01
05415067033017Epic™E200-21AE200-21A2021-12-09
05415067033024Epic™E200-23AE200-23A2021-12-09
05415067033031Epic™E200-25AE200-25A2021-12-09
05415067033048Epic™E200-25ME200-25M2021-12-09
05415067033055Epic™E200-27AE200-27A2021-12-09
05415067033062Epic™E200-27ME200-27M2021-12-09
05415067033079Epic™E200-29AE200-29A2021-12-09
05415067033086Epic™E200-29ME200-29M2021-12-09
05415067033093Epic™E200-31ME200-31M2021-12-09
05415067033109Epic™E200-33ME200-33M2021-12-09
05415067033116Epic™ESP200-19ESP200-192021-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811806011295Amplatzer™ST. JUDE MEDICAL, INC.MLV2026-07-31
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
05415067033345Amplatzer™ 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
00733132606979GORE HELEX Septal OccluderW. L. Gore & Associates, Inc.MLV2017-02-13
00733132606986GORE HELEX Septal OccluderW. L. Gore & Associates, Inc.MLV2017-02-13
00733132606993GORE HELEX Septal OccluderW. L. Gore & Associates, Inc.MLV2017-02-13
00733132607006GORE HELEX Septal OccluderW. L. Gore & Associates, Inc.MLV2017-02-13
00733132607013GORE HELEX Septal OccluderW. L. Gore & Associates, Inc.MLV2017-02-13
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