Approval for a manufacturing site located at le maitre vascular inc. , 63 second ave, burlington, massachusetts, for manufacturing operations for procol vascular bioprosthesis.
| 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 | 2017-12-08 |
| Decision Date | 2018-03-22 |
| PMA | P020049 |
| Supplement | S005 |
| 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