COMPLETE SE VASCULAR STENT SYSTEM

Stent, Superficial Femoral Artery

FDA Premarket Approval P110040 S006

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for implementing the supplier owned quality (soq) program.

• Device: COMPLETE SE VASCULAR STENT SYSTEM
• Classification Name: Stent, Superficial Femoral Artery
• Generic Name: Stent, Superficial Femoral Artery
• Applicant: Medtronic Vascular
• Date Received: 2015-03-20
• Decision Date: 2015-07-09
• PMA: P110040
• Supplement: S006
• Product Code: NIP
• Advisory Committee: Cardiovascular
• Supplement Type: 135 Review Track For 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: Medtronic Vascular 3576 Unocal Place santa Rosa, CA 95403

Supplemental Filings

Supplement Number	Date	Supplement Type
P110040		Original Filing
S011	2016-08-17	135 Review Track For 30-day Notice
S010	2016-07-13	30-day Notice
S009	2016-05-05	30-day Notice
S008	2015-09-24	30-day Notice
S007	2015-06-15	Normal 180 Day Track No User Fee
S006	2015-03-20	135 Review Track For 30-day Notice
S005	2014-03-04	30-day Notice
S004	2014-01-30	30-day Notice
S003	2014-01-09	30-day Notice
S002	2013-12-16	30-day Notice
S001	2013-11-01	30-day Notice

NIH GUDID Devices

Device ID	PMA	Supp
00643169150829	P110040	000
00643169150645	P110040	000
00643169150652	P110040	000
00643169150669	P110040	000
00643169150676	P110040	000
00643169150737	P110040	000
00643169150744	P110040	000
00643169150751	P110040	000
00643169150768	P110040	000
00643169150775	P110040	000
00643169150782	P110040	000
00643169150799	P110040	000
00643169150805	P110040	000
00643169150812	P110040	000
00643169150638	P110040	000