VITAGEL RT3 SURGICAL HEMOSTAT
FDA premarket approval P050044/S025 · decided 2013-11-15
Approval details
- PMA number
- P050044
- Supplement
- S025
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VITAGEL RT3 SURGICAL HEMOSTAT
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Stryker Corp.
- Date received
- 2013-10-22
- Decision date
- 2013-11-15
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Kalamazoo, MI
- Statement
- APPROVAL FOR A DEVICE NAME CHANGE FOR THE VITAGEL RT SURGICAL HEMOSTAT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VITAGEL RT3 SURGICAL HEMOSTAT WITH NO CHANGE IN THE INDICATIONS FOR USE.
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