|
Device | SURGICEL/SURGICEL NU-KNIT/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 | S018 |
Date Received | 07/25/2003 |
Decision Date | 08/20/2003 |
Product Code |
LMG |
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 LABELING CHANGE TO INCLUDE FOUR ANTIBIOTIC RESISTANT BACTERIAL STRAINS TO THE EXISTING LIST OF BACTERIAL STRAINS. |