VITAGEL RT3 SURGICAL HEMOSTAT
FDA premarket approval P050044/S032 · decided 2015-07-16
Approval details
- PMA number
- P050044
- Supplement
- S032
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VITAGEL RT3 SURGICAL HEMOSTAT
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Stryker Corp.
- Date received
- 2015-06-16
- Decision date
- 2015-07-16
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Kalamazoo, MI
- Statement
- MODIFICATIONS TO THE ON-GOING REAL TIME STABILITY STUDY WHICH IS USED FOR ESTABLISHING SHELF LIFE FOR VITAGEL RT3 SURGICAL HEMOSTAT.
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