ARTERX SURGICAL SEALANT
FDA premarket approval P100030 · decided 2013-03-01
Approval details
- PMA number
- P100030
- Trade name
- ARTERX SURGICAL SEALANT
- Generic name
- Sealant, polymerizing
- Applicant
- Baxter Healthcare Corporation
- Date received
- 2010-07-27
- Decision date
- 2013-03-01
- Days to decision
- 948 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Deerfield Lake, IL
- Statement
- APPROVAL FOR THE ARTERX SURGICAL SEALANT. THIS DEVICE IS INDICATED FOR USE IN VASCULAR RECONSTRUCTIONS TO ACHIEVE ADJUNCTIVE HEMOSTASIS BY MECHANICALLY SEALING AREAS OF LEAKAGE.
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