|
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 | S029 |
Date Received | 07/23/2014 |
Decision Date | 12/12/2014 |
Withdrawal Date
|
07/10/2019 |
Product Code |
LMF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE RELOCATION OF CERTAIN MANUFACTURING EQUIPMENT USED FOR ASSEMBLY AND PACKAGING OF VITAGEL RT3 SURGICAL HEMOSTAT FROM ONE ROOM TO ANOTHER ROOM WITHIN THE FIRMS MALVERN, PENNSYLVANIA FACILITY. |