Preveleak Surgical Sealant
FDA premarket approval P100030/S013 · decided 2021-01-26
Approval details
- PMA number
- P100030
- Supplement
- S013
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Preveleak Surgical Sealant
- Generic name
- Sealant, polymerizing
- Applicant
- Baxter Healthcare Corporation
- Date received
- 2018-12-21
- Decision date
- 2021-01-26
- Days to decision
- 767 days
- Decision code
- APPR
- Product code
- NBE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Deerfield Lake, IL
- Statement
- Approval for an alternate supplier of chitosan chloride and a modification to the preparation steps of the proteinaceous solution component of Preveleak Surgical Sealant.
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