|
Device | VITAGEL SURGICAL HEMOSTAT (VITAGEL) |
Generic Name | Agent, absorbable hemostatic, collagen based |
Regulation Number | 878.4490 |
Applicant | STRYKER CORP. 2825 AIRVIEW BOULEVARD PORTAGE, MI 49002 |
PMA Number | P050044 |
Supplement Number | S026 |
Date Received | 11/14/2013 |
Decision Date | 02/11/2014 |
Withdrawal Date
|
07/10/2019 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE FOLLOWING CHANGES TO THE VITAPREP PLASMA SEPARATOR COMPONENT OF VITAGEL SURGICAL HEMOSTAT: ADDITION OF HYDRAFOAM AND SILICONE O-RING INSERTS TO THE INSIDE OF THE CAP, INCREASE IN THE LENGTH OF THE PLUNGER STOPPER SUPPORT, REMOLDING OF THE CAP, AND UPDATE IN THE PRIMARY PACKAGING. |