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Device | COLLASTAT INSTAT ABSORABLE COLLAGEN HEMOSTATIC SPONGE,COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT-MICROFIBRILLAR FORM |
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 | S060 |
Date Received | 02/24/2015 |
Decision Date | 03/26/2015 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ENHANCED COMPRESSOR CONFIGURATION. |