|
Device | COLLASTAT ABSORBABLE 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 | S020 |
Date Received | 06/08/2001 |
Decision Date | 07/05/2001 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE REMOVAL OF THE NEUROLOGICAL EXCLUSION FROM THE INDICATIONS STATEMENT. |