|
Device | COLLASTAT MICROFIBRILLAR HEMOSTATIC SPONGE |
Generic Name | Agent, absorbable hemostatic, collagen based |
Regulation Number | 878.4490 |
Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. PLAINSBORO, NJ 08536 |
PMA Number | P810006 |
Supplement Number | S019 |
Date Received | 07/26/1995 |
Decision Date | 09/12/1995 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ALTERNATE STERILIZATION FACILITY FOR COLLASTAT MICROFIBRILLAR HEMOSTATIC SPONGE AT GRIFFITH MICROSCIENCE, INC. 27 PARK ROAD, GLEN FALLS, NY 12801 |