|
Device | INSTAT COLLAGEN 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 | S015 |
Date Received | 04/28/2004 |
Decision Date | 06/22/2004 |
Withdrawal Date
|
10/18/2021 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A NEW STERILIZATION SITE LOCATED AT STERIS ISOMEDIX SERVICES, VEGA ALTA, PUERTO RICO; AND A LOWERED MINIMUM RADIATION STERILIZATION DOSE. |