|
Device | COLLASTAT ABSORBABLE 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 | S036 |
Date Received | 05/01/2013 |
Decision Date | 11/29/2013 |
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 |
Approval Order Statement APPROVAL FOR THE FOLLOWING PROPOSED CHANGES: 1) CHANGE IN CLEANING DETERGENTS; 2) ESTABLISHMENT OF EQUIPMENT DIRTY HOLD TIMES (DHT); AND 3) PROPOSED USE OF TOTAL ORGANIC CARBONS (TOCS) AS A METHOD TO TEST FOR RESIDUES. |