PMA P030054S435

Device: Quartet; QuickFlex Micro
Applicant: ABBOTT MEDICAL
PMA number: P030054
Supplement: S435
Product code: NIK
Decision date: 2026-02-19
Classification: Cardiovascular
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: an alternative sterilization site (Cycle 100 in Chamber 1 and 2, Abbott, Arecibo, PR) for analytical test articles (non-finished goods) comprising several cardiac leads and Aveir Leadless Pacemakers Monolithic Controlled Release Devices (MCRDs)

Current openFDA PMA Record#

Device: Quartet; QuickFlex Micro
Applicant: ABBOTT MEDICAL
PMA number: P030054
Supplement: S435
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2026-02-19
Decision code: APPR
Date received: 2025-05-12
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: an alternative sterilization site (Cycle 100 in Chamber 1 and 2, Abbott, Arecibo, PR) for analytical test articles (non-finished goods) comprising several cardiac leads and Aveir Leadless Pacemakers Monolithic Controlled Release Devices (MCRDs)