PMA P050044S026
- Device
- VITAGEL SURGICAL HEMOSTAT (VITAGEL)
- Applicant
- Stryker Corp.
- PMA number
- P050044
- Supplement
- S026
- Product code
- LMF
- Decision date
- 2014-02-11
- Classification
- Agent, Absorbable Hemostatic, Collagen Based
- Generic name
- Agent, absorbable hemostatic, collagen based
- 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.
Current openFDA PMA Record#
- Device
- VITAGEL SURGICAL HEMOSTAT (VITAGEL)
- Applicant
- Stryker Corp.
- PMA number
- P050044
- Supplement
- S026
- Product code
- LMF
- Generic name
- Agent, absorbable hemostatic, collagen based
- Decision date
- 2014-02-11
- Decision code
- APPR
- Date received
- 2013-11-14
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- 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.