PMA P120020S036

Device: Supera™ Peripheral Stent System
Applicant: Abbott Vascular (Idef Technologies Inc)
PMA number: P120020
Supplement: S036
Product code: NIP
Decision date: 2026-03-20
Classification: Cardiovascular
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement: approval of a modified sterilization cycle at chamber C, 7, and 8 at Sterigenics Los Angeles and chamber 2 and 3 at Sterigenics Costa Rica

Current openFDA PMA Record#

Device: Supera™ Peripheral Stent System
Applicant: Abbott Vascular (Idef Technologies Inc)
PMA number: P120020
Supplement: S036
Product code: NIP
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Decision date: 2026-03-20
Decision code: OK30
Date received: 2026-02-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval of a modified sterilization cycle at chamber C, 7, and 8 at Sterigenics Los Angeles and chamber 2 and 3 at Sterigenics Costa Rica