PROCOL VASCULAR BIOPROSTHESIS

Tissue Graft Of 6mm And Greater

FDA Premarket Approval P020049

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the procol vascular bioprosthesis. The device is indicated for the creation of a bridge graft for vascular access subsequent to at least one previously failed prosthetic access graft.

• Device: PROCOL VASCULAR BIOPROSTHESIS
• Classification Name: Tissue Graft Of 6mm And Greater
• Generic Name: Tissue Graft Of 6mm And Greater
• Applicant: LEMAITRE VASCULAR INC
• Date Received: 2002-11-12
• Decision Date: 2003-07-29
• Notice Date: 2003-08-07
• PMA: P020049
• Supplement: S
• Product Code: LXA
• Docket Number: 03M-0352
• Advisory Committee: Cardiovascular
• Expedited Review: No
• Combination Product: No
• Applicant Address: LEMAITRE VASCULAR INC 63 Second Avenue burlington, MA 01803
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P020049		Original Filing
S007	2018-08-20	30-day Notice
S006	2018-06-29	Normal 180 Day Track No User Fee
S005	2017-12-08	Normal 180 Day Track No User Fee
S004	2014-10-01	30-day Notice
S003	2014-07-11	Normal 180 Day Track No User Fee
S002	2010-02-22	30-day Notice
S001	2009-09-17	30-day Notice

NIH GUDID Devices

Device ID	PMA	Supp
00840663108688	P020049	000
00840663108671	P020049	000
00840663108664	P020049	000
00840663108657	P020049	000