PMA P010012S592

Device: NG3 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds): DYNAGEN Models: G150, G151, G154, G156, G158; INOGEN Mode
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S592
Product code: NIK
Decision date: 2026-01-08
Classification: Cardiovascular
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: an alternative sterilization cycle for pulse generator devices on the Getinge GP1 sterilizer

Current openFDA PMA Record#

Device: NG3 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds): DYNAGEN Models: G150, G151, G154, G156, G158; INOGEN Mode
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S592
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2026-01-08
Decision code: APPR
Date received: 2025-07-15
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: an alternative sterilization cycle for pulse generator devices on the Getinge GP1 sterilizer