|
Device | HELISTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENTS |
Generic Name | Agent, absorbable hemostatic, collagen based |
Regulation Number | 878.4490 |
Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DR. PLAINSBORO, NJ 08540 |
PMA Number | P850010 |
Supplement Number | S029 |
Date Received | 02/02/2009 |
Decision Date | 03/26/2009 |
Product Code |
LMF |
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 AN ALTERNATE PRODUCTION FACILITY LOCATED AT INTEGRA NEUROSCIENCES PR, INC., FOR SEVERAL PRODUCTION STEPS FOR THE DEVICES. |