|
Device | HELISTAT, HELITENE 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 | S042 |
Date Received | 07/31/2013 |
Decision Date | 08/29/2013 |
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 INCREASE IN THE SAMPLE SIZE FOR BACTERIAL ENDOTOXIN TESTING (BET) FOR ALL COLLAGEN PRODUCTS MANUFACTURED AT THE PLAINSBORO NEW JERSEY FACILITY AND AT THE ANASCO, PUERTO RICO LOCATION. |