FDA.reportPublic FDA data

Amplatzer™

Primary DI
05415067019257
Brand
Amplatzer™
Company
AGA MEDICAL CORPORATION
Model
9-ASD-017
Catalog number
9-ASD-017
Device description
Septal Occluder
Published
2015-01-27
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
05415067019257PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067019257054150670192575415067019257

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 Diameter17Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00STORE IN DRY PLACE.
Special Storage Condition, Specify00STORE IN DRY PLACE.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
966215829
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811806014111AMPLATZER™9-TV45X45-14F-1009-TV45X45-14F-1002015-03-09
05415067019127Amplatzer™9-ASD-0049-ASD-0042015-01-27
05415067019134AMPLATZER™9-ASD-0059-ASD-0052015-01-27
05415067019141AMPLATZER™9-ASD-0069-ASD-0062015-01-27
05415067019158AMPLATZER™9-ASD-0079-ASD-0072015-01-27
05415067019165AMPLATZER™9-ASD-0089-ASD-0082015-01-27
05415067019172AMPLATZER™9-ASD-0099-ASD-0092015-01-27
05415067019189AMPLATZER™9-ASD-0109-ASD-0102015-01-27
05415067019196AMPLATZER™9-ASD-0119-ASD-0112015-01-27
05415067019202AMPLATZER™9-ASD-0129-ASD-0122015-01-27
05415067019219Amplatzer™9-ASD-0139-ASD-0132015-01-27
05415067019226Amplatzer™9-ASD-0149-ASD-0142015-01-27
05415067019233Amplatzer™9-ASD-0159-ASD-0152015-01-27
05415067019240Amplatzer™9-ASD-0169-ASD-0162015-01-27
05415067019264Amplatzer™9-ASD-0189-ASD-0182015-01-27
05415067019271Amplatzer™9-ASD-0199-ASD-0192015-01-27
05415067019288Amplatzer™9-ASD-0209-ASD-0202015-01-27
05415067019295Amplatzer™9-ASD-0229-ASD-0222015-01-27
05415067019301Amplatzer™9-ASD-0249-ASD-0242015-01-27
05415067019318Amplatzer™9-ASD-0269-ASD-0262015-01-27

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
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
00811806011271Amplatzer™ST. JUDE MEDICAL, INC.MLV2016-11-08