PROCOL VASCULAR BIOPROSTHESIS

Tissue Graft Of 6mm And Greater

FDA Premarket Approval P020049 S004

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

Alternate supplier for bovine veins.

DevicePROCOL VASCULAR BIOPROSTHESIS
Classification NameTissue Graft Of 6mm And Greater
Generic NameTissue Graft Of 6mm And Greater
ApplicantLEMAITRE VASCULAR INC
Date Received2014-10-01
Decision Date2014-10-31
PMAP020049
SupplementS004
Product CodeLXA
Docket NumberPremarket 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 CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address LEMAITRE VASCULAR INC 63 Second Avenue burlington, MA 01803

Supplemental Filings

Supplement NumberDateSupplement Type
P020049Original 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 IDPMASupp
00840663108688 P020049 000
00840663108671 P020049 000
00840663108664 P020049 000
00840663108657 P020049 000

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