|
Device | PROCOL VASCULAR BIOPROSTHESIS |
Generic Name | Tissue graft of 6mm and greater |
Applicant | LEMAITRE VASCULAR INC 63 SECOND AVENUE BURLINGTON, MA 01803 |
PMA Number | P020049 |
Supplement Number | S002 |
Date Received | 02/22/2010 |
Decision Date | 03/23/2010 |
Withdrawal Date
|
12/15/2023 |
Product Code |
LXA |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITION OF A NEW DISTRIBUTION SITE. |