|
Device | COLLASTAT/ INSTAT ABSORBALE COLLAGEN HEMOSTATIC AGENTS |
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 | S059 |
Date Received | 02/18/2015 |
Decision Date | 03/20/2015 |
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 ADDITION OF A NEW ETHANOL SQUEEZE DEVICE TO REPLACE THE HAND SQUEEZING PROCESS CURRENTLY USED DURING MANUFACTURE OF THE DEVICES. |