|
Device | SURGICEL FIBRILLAR ABSORBABLE HEMOSTATT |
Generic Name | Agent, absorbable hemostatic, non-collagen based |
Regulation Number | 878.4490 |
Applicant | ETHICON, INC. 1000 Route 202 Raritan, NJ 08869 |
PMA Number | N12159 |
Supplement Number | S016 |
Date Received | 03/04/1996 |
Decision Date | 05/15/1996 |
Product Code |
LMG |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE 4"X4" SIZE OF SURGICEL FIBRILLAR ABSORBABLE HEMOSTAT |