|
Device | HELISTAT ABSORABABLE COLLAGEN HEMOSTATIC AGENT MICROFIBRILLAR |
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 | S044 |
Date Received | 08/14/2013 |
Decision Date | 04/08/2014 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE FOLLOWING PROPOSED CHANGES: 1) CLEANING VALIDATION FOR THE MICROFIBRILLAR GRINDING PROCESS EQUIPMENT; 2) ESTABLISHMENT OF DIRTY HOLD TIME;3) TOTAL ORGANIC CARBON (TOC) RECOVERY STUDY FOR SWAB AND RINSE ON STAINLESS STEEL SURFACES; AND4) TOC RECOVERY STUDY FOR SWAB AND RINSE ON TEFLON SURFACES. |