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.
Alternate abattoir.
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 | 2009-09-17 |
Decision Date | 2009-10-08 |
PMA | P020049 |
Supplement | S001 |
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 | 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
Expedited Review | No |
Combination Product | No |
Applicant Address | LEMAITRE VASCULAR INC 63 Second Avenue burlington, MA 01803 |
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 |
Device ID | PMA | Supp |
---|---|---|
00840663108688 | P020049 | 000 |
00840663108671 | P020049 | 000 |
00840663108664 | P020049 | 000 |
00840663108657 | P020049 | 000 |