|
Device | VITAGEL 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 | S016 |
Date Received | 01/18/2011 |
Decision Date | 02/04/2011 |
Withdrawal Date
|
07/10/2019 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR AN ADDITIONAL IN- PROCESS INSPECTION OF THE TRANSFER SYRINGES TO VISUALLY CHECK THAT THE CAPS ARE PRESENT AND APPROPRIATELY TIGHTENED. |