PMA P010012S538

Device: CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S538
Product code: NIK
Decision date: 2021-05-10
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: Add a new pallet sterilization chamber at the Arden Hills facility to increase sterilization capacity.

Current openFDA PMA Record#

Device: CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S538
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
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.