PMA P120020S014

Device: SUPERA PERIPHERAL STENT SYSTEM
Applicant: Abbott Vascular (Idef Technologies Inc)
PMA number: P120020
Supplement: S014
Product code: NIP
Decision date: 2017-02-01
Classification: Stent, Superficial Femoral Artery
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Approval order statement: Approval for the removal of the in-process dimensional inspection of the nitinol wire diameter before and after the passivation process.

Current openFDA PMA Record#

Device: SUPERA PERIPHERAL STENT SYSTEM
Applicant: Abbott Vascular (Idef Technologies Inc)
PMA number: P120020
Supplement: S014
Product code: NIP
Generic name: STENT, SUPERFICIAL FEMORAL ARTERY
Decision date: 2017-02-01
Decision code: APPR
Date received: 2016-08-30
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for the removal of the in-process dimensional inspection of the nitinol wire diameter before and after the passivation process.