Preveleak Surgical Sealant 4mL; Preveleak Delivery Tips 10 PK
FDA premarket approval P100030/S020 · decided 2025-04-11
Approval details
- PMA number
- P100030
- Supplement
- S020
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Preveleak Surgical Sealant 4mL; Preveleak Delivery Tips 10 PK
- Generic name
- Sealant, polymerizing
- Applicant
- Baxter Healthcare Corporation
- Date received
- 2025-03-12
- Decision date
- 2025-04-11
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NBE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Deerfield Lake, IL
- Statement
- performing the endotoxin testing in-house at the Baxter Hayward facility for Preveleak Surgical Sealant
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510(k) clearances by this applicant
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|---|---|---|
| Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) (K251745) | Baxter Healthcare Corporation | 2025-12-16 |
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| Solution Administration Sets (K243529) | Baxter Healthcare Corporation | 2025-03-14 |
| Intravascular Extension Sets and Accessories (K242339) | Baxter Healthcare Corporation | 2025-02-28 |
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| Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS (K241564) | Baxter Healthcare Corporation | 2024-08-02 |
| Novum IQ Large Volume Pump (K211122) | Baxter Healthcare Corporation | 2024-03-29 |