VITAGEL RT3 DELIVERY SYSTEM
FDA premarket approval P050044/S028 · decided 2014-06-05
Approval details
- PMA number
- P050044
- Supplement
- S028
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VITAGEL RT3 DELIVERY SYSTEM
- Generic name
- Agent, absorbable hemostatic, collagen based
- Applicant
- Stryker Corp.
- Date received
- 2014-03-07
- Decision date
- 2014-06-05
- Days to decision
- 90 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 BA-02 DELIVERY SYSTEM COMPONENT OF VITAGEL RT3 SURGICAL HEMOSTAT: REPLACEMENT OF THE CURRENT SYRINGE CLIP AND SYRINGE SUPPORT COMPONENTS WITH A TWIN SYRINGE DISPENSER, REPLACEMENT OF THE CURRENT JOINER COMPONENT WITH A ROTATING LUER ADAPTER (SYRINGE ADAPTER) TO THE DISTAL LUER CONNECTIONS OF THE EXTENDED APPLICATORS, CHANGES IN MATERIALS OF CONSTRUCTION AND MANUFACTURERS OF THE AFOREMENTIONED COMPONENTS AND UPDATE IN THE PRIMARY PACKAGING. ADDITIONALLY,
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