PREVELEAK Surgical Sealant
FDA premarket approval P100030/S015 · decided 2021-07-27
Approval details
- PMA number
- P100030
- Supplement
- S015
- Supplement type
- 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
- 2021-06-28
- Decision date
- 2021-07-27
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NBE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Deerfield Lake, IL
- Statement
- Change in location for the quality control testing performed on the PreveLeak, from the Baxter Mountain View to Baxter Hayward facilities.
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