|
Device | SURGICEL ORGINAL/SURGICEL FIBRILLAR/SURGICEL NU-KNIT ABSORABLE HEMOSTATS |
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 | S025 |
Date Received | 01/07/2010 |
Decision Date | 02/04/2010 |
Product Code |
LMG |
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 TRANSFER OF ONE PROCESS IN THE MANUFACTURE OF A COMPONENT OF THE SURGICEL HEMOSTATS TO THE CURRENT CONTRACT SUPPLIER. |