|
Device | INSTAT COLLAGEN ABSORBABLE HEMOSTAT |
Generic Name | Agent, absorbable hemostatic, collagen based |
Regulation Number | 878.4490 |
Applicant | ETHICON, INC. ROUTE 22 WEST P.O. BOX 151 SOMERVILLE, NJ 08876-0151 |
PMA Number | P830079 |
Supplement Number | S017 |
Date Received | 06/01/2007 |
Decision Date | 11/28/2007 |
Withdrawal Date
|
10/18/2021 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF THE MANUFACTURING FACILITY LOCATED IN NORTH YORKSHIRE, UNITED KINGDOM. |