|
Device | VITAGEL RT3 SURGICAL HEMOSTAT |
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 | S025 |
Date Received | 10/22/2013 |
Decision Date | 11/15/2013 |
Withdrawal Date
|
07/10/2019 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A DEVICE NAME CHANGE FOR THE VITAGEL RT SURGICAL HEMOSTAT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITAGEL RT3 SURGICAL HEMOSTAT WITH NO CHANGE IN THE INDICATIONS FOR USE. |