ARTERX SURGICAL SEALANT 2.5ML AND 5.0 FILL VOLUMES
FDA premarket approval P100030/S001 · decided 2013-11-25
Approval details
- PMA number
- P100030
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ARTERX SURGICAL SEALANT 2.5ML AND 5.0 FILL VOLUMES
- Generic name
- Sealant, polymerizing
- Applicant
- Baxter Healthcare Corporation
- Date received
- 2013-09-03
- Decision date
- 2013-11-25
- Days to decision
- 83 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Deerfield Lake, IL
- Statement
- APPROVAL FOR THE ADDITION OF 2.5ML AND 5.0ML FILL VOLUMES TO THE EXISTING 4.0ML FILL VOLUME, USING THE SAME 5ML SYRINGE AND PACKAGING.
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