FDA.reportPublic FDA data

Amplatzer™

Primary DI
05415067057310
Brand
Amplatzer™
Company
ST. JUDE MEDICAL, INC.
Model
9-APVL-125
Catalog number
9-APVL-125
Device description
Paraclose PVL Occluder
Published
2026-11-02
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
SJTPara-device leak occluder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SJTPara-device leak occluder

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P260019000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P260019000Amplatzer Paraclose PVL OccluderABBOTT MEDICAL2026-10-27SJT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067057310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067057310054150670573105415067057310

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry

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
05415067057242Amplatzer™9-APVL-1439-APVL-1432026-11-02
05415067057259Amplatzer™9-APVL-0849-APVL-0842026-11-02
05415067057266Amplatzer™9-APVL-1239-APVL-1232026-11-02
05415067057273Amplatzer™9-APVL-0639-APVL-0632026-11-02
05415067057280Amplatzer™9-APVL-1059-APVL-1052026-11-02
05415067057297Amplatzer™9-APVL-0429-APVL-0422026-11-02
05415067057303Amplatzer™9-APVL-1039-APVL-1032026-11-02
05415067057327Amplatzer™9-APVL-1459-APVL-1452026-11-02
05414734008242Fast-Cath™4061044061042015-03-20
05414734008266Fast-Cath™4061204061202015-03-20
05414734008280Fast-Cath™4061284061282015-03-20
05414734008303Fast-Cath™4061404061402015-03-12
05414734008327Fast-Cath™4061624061622015-02-28
05414734008341Maximum™4062504062502015-04-11
05414734008365Maximum™4062514062512015-04-11
05414734008389Maximum™4062524062522015-04-11
05414734008402Maximum™4062534062532015-04-11
05414734008426Maximum™4062554062552015-04-10
05414734008488Maximum™4062594062592015-04-11
05414734008501Maximum™4063474063472015-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415067057242Amplatzer™ST. JUDE MEDICAL, INC.SJT2026-11-02
05415067057259Amplatzer™ST. JUDE MEDICAL, INC.SJT2026-11-02
05415067057266Amplatzer™ST. JUDE MEDICAL, INC.SJT2026-11-02
05415067057273Amplatzer™ST. JUDE MEDICAL, INC.SJT2026-11-02
05415067057280Amplatzer™ST. JUDE MEDICAL, INC.SJT2026-11-02
05415067057297Amplatzer™ST. JUDE MEDICAL, INC.SJT2026-11-02
05415067057303Amplatzer™ST. JUDE MEDICAL, INC.SJT2026-11-02
05415067057327Amplatzer™ST. JUDE MEDICAL, INC.SJT2026-11-02