PMA P100030S016
- Device
- Preveleak Surgical Sealant, Preveleak Delivery Tips - 1O pack
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P100030
- Supplement
- S016
- Product code
- NBE
- Decision date
- 2021-12-09
- Generic name
- Sealant, polymerizing
- Approval order statement
- Additional location for quarterly dose audits for the Preveleak device.
Current openFDA PMA Record#
- Device
- Preveleak Surgical Sealant, Preveleak Delivery Tips - 1O pack
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P100030
- Supplement
- S016
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2021-12-09
- Decision code
- OK30
- Date received
- 2021-11-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional location for quarterly dose audits for the Preveleak device.