VITAGEL SURGICAL HEMOSTAT
FDA premarket approval P050044/S005 · decided 2008-05-30
Approval details
- PMA number
- P050044
- Supplement
- S005
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VITAGEL SURGICAL HEMOSTAT
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Stryker Corp.
- Date received
- 2008-05-19
- Decision date
- 2008-05-30
- Days to decision
- 11 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Kalamazoo, MI
- Statement
- APPROVAL TO CHANGE THE VENDOR OF THE 1 LITER AND 5 LITER MEDIA BAGS USED TO STORE INTERMEDIAE SOLUTIONS DURING VITAGEL ASEPTIC PROCESSING.
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