PMA P830060S086

Device: VENTAK AND AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS
Applicant: Boston Scientific
PMA number: P830060
Supplement: S086
Product code: LWS
Decision date: 2021-05-10
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: Add a new pallet sterilization chamber at the Arden Hills facility to increase sterilization capacity.

Current openFDA PMA Record#

Device: VENTAK AND AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEMS
Applicant: Boston Scientific
PMA number: P830060
Supplement: S086
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 2021-05-10
Decision code: OK30
Date received: 2021-04-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Add a new pallet sterilization chamber at the Arden Hills facility to increase sterilization capacity.