PreveLeak Surgical Sealant
FDA premarket approval P100030/S007 · decided 2017-08-25
Approval details
- PMA number
- P100030
- Supplement
- S007
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PreveLeak Surgical Sealant
- Generic name
- Sealant, polymerizing
- Applicant
- Baxter Healthcare Corporation
- Date received
- 2017-05-30
- Decision date
- 2017-08-25
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Deerfield Lake, IL
- Statement
- Approval for changes to the pH specification and the ratio of salts for the crosslinker solution component
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