PreveLeak Surgical Sealant / PreveLeak Surgical Sealant 10pk applicator tips
FDA premarket approval P100030/S010 · decided 2017-08-21
Approval details
- PMA number
- P100030
- Supplement
- S010
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PreveLeak Surgical Sealant / PreveLeak Surgical Sealant 10pk applicator tips
- Generic name
- Sealant, polymerizing
- Applicant
- Baxter Healthcare Corporation
- Date received
- 2017-07-26
- Decision date
- 2017-08-21
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- NBE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Deerfield Lake, IL
- Statement
- Use of an alternative 10-pack shipping case.
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