|
Device | SURGICEL* FIBRILLAR ABSORBABLE HEMOSTAT |
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 | S015 |
Date Received | 09/01/1995 |
Decision Date | 02/01/1996 |
Product Code |
LMG |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING CHANGE WHICH ADDS A STEP TO FORM A FIBRILLAR STRUCTURE FOR THE DEVICE. AS MODIFIED THE DEVICE WILL MARKETED UNDER THE TRADE NAME SURGICEL |