PMA P830060S087

Device: Ventak and Automatic Implantable Cardioverter Defibrillator (AICD) Systems
Applicant: Boston Scientific
PMA number: P830060
Supplement: S087
Product code: LWS
Decision date: 2021-10-04
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: Alternate stylet tip forming and inspection manufacturing processes that are performed at the supplier.

Current openFDA PMA Record#

Device: Ventak and Automatic Implantable Cardioverter Defibrillator (AICD) Systems
Applicant: Boston Scientific
PMA number: P830060
Supplement: S087
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 2021-10-04
Decision code: OK30
Date received: 2021-09-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Alternate stylet tip forming and inspection manufacturing processes that are performed at the supplier.