RT3 SURGICAL HEMOSTAT
FDA premarket approval P050044/S027 · decided 2014-01-27
Approval details
- PMA number
- P050044
- Supplement
- S027
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RT3 SURGICAL HEMOSTAT
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Stryker Corp.
- Date received
- 2013-11-29
- Decision date
- 2014-01-27
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- LMF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Kalamazoo, MI
- Statement
- APPROVAL OF THE TRANSFER OF STERILITY TESTING OF VITAGEL RT3 FILLED SYRINGES INHOUSE.
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