ProCol Vascular Bioprosthesis

Tissue Graft Of 6mm And Greater

FDA Premarket Approval P020049 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

For a manufacturing site located at isomedix operations, inc. , 435 whitney street, northborough, massachusetts, for sterilization of the procol vascular bioprothesis

• 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: 2018-06-29
• Decision Date: 2018-09-28
• PMA: P020049
• Supplement: S006
• Product Code: LXA
• Docket Number: Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Location Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: LEMAITRE VASCULAR INC 63 Second Avenue burlington, MA 01803

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