|
Device | SEPRAFILM |
Generic Name | Barrier, absorbable, adhesion |
Applicant | Baxter Healthcare Corporation One Baxter Parkway Deerfield, IL 60015 |
PMA Number | P950034 |
Supplement Number | S041 |
Date Received | 02/16/2012 |
Decision Date | 04/04/2012 |
Product Code |
MCN |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT GENZYME NORTHBOROUGH OPERATIONS CENTER (GNOC) IN NORTHBOROUGH, MASSACHUSETTS. |