PMA P100030S020
- Device
- Preveleak Surgical Sealant 4mL; Preveleak Delivery Tips 10 PK
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P100030
- Supplement
- S020
- Product code
- NBE
- Decision date
- 2025-04-11
- Classification
- Cardiovascular
- Generic name
- Sealant, polymerizing
- Approval order statement
- performing the endotoxin testing in-house at the Baxter Hayward facility for Preveleak Surgical Sealant
Current openFDA PMA Record#
- Device
- Preveleak Surgical Sealant 4mL; Preveleak Delivery Tips 10 PK
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P100030
- Supplement
- S020
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2025-04-11
- Decision code
- OK30
- Date received
- 2025-03-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- performing the endotoxin testing in-house at the Baxter Hayward facility for Preveleak Surgical Sealant