PMA P100030
- Device
- Preveleak Surgical Sealant
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P100030
- Supplement
- S016
- Product code
- NBE
- Decision date
- 2025-07-10
- Generic name
- Sealant, polymerizing
- Approval order statement
- an updated DMA test procedure used for product release
Current openFDA PMA Record#
- Device
- Preveleak Surgical Sealant
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P100030
- Supplement
- S021
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2025-07-10
- Decision code
- OK30
- Date received
- 2025-06-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an updated DMA test procedure used for product release