ARTERX SURGICAL SEALANT,
FDA premarket approval P100030/S002 · decided 2013-11-05
Approval details
- PMA number
- P100030
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ARTERX SURGICAL SEALANT,
- Generic name
- Sealant, polymerizing
- Applicant
- Baxter Healthcare Corporation
- Date received
- 2013-09-03
- Decision date
- 2013-11-05
- Days to decision
- 63 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Deerfield Lake, IL
- Statement
- APPROVAL TO EXTEND THE SHELF LIFE FOR ARTERX SURGICAL SEALANT FROM 12 MONTHS TO 24 MONTHS WHEN STORED AT2-8C AND TO EXTEND THE SHELF LIFE FOR THE ARTERX DELIVERY TIPS FROM 12 MONTHS TO 42 MONTHS.
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