Preveleak Surgical Sealant, Preveleak I 0-pack delivery tips
FDA premarket approval P100030/S018 · decided 2023-11-29
Approval details
- PMA number
- P100030
- Supplement
- S018
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Preveleak Surgical Sealant, Preveleak I 0-pack delivery tips
- Generic name
- Sealant, polymerizing
- Applicant
- Baxter Healthcare Corporation
- Date received
- 2023-10-31
- Decision date
- 2023-11-29
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Deerfield Lake, IL
- Statement
- Approval for a manufacturing site located at Hayward, California to manufacture the Preveleak Sealant, 4mL and delivery tips.
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