- Device
- Preveleak Surgical Sealant, Preveleak I 0-pack delivery tips
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P100030
- Supplement
- S018
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2023-11-29
- Decision code
- APPR
- Date received
- 2023-10-31
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at Hayward, California to manufacture the Preveleak Sealant, 4mL and delivery tips.