VITAGEL SURGICAL HEMOSTAT (VITAGEL)
FDA premarket approval P050044/S026 · decided 2014-02-11
Approval details
- PMA number
- P050044
- Supplement
- S026
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VITAGEL SURGICAL HEMOSTAT (VITAGEL)
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Stryker Corp.
- Date received
- 2013-11-14
- Decision date
- 2014-02-11
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Kalamazoo, MI
- 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.
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