PMA P100030S007
- Device
- PreveLeak Surgical Sealant
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P100030
- Supplement
- S007
- Product code
- NBE
- Decision date
- 2017-08-25
- Classification
- Sealant, Polymerizing
- Generic name
- Sealant, polymerizing
- Approval order statement
- Approval for changes to the pH specification and the ratio of salts for the crosslinker solution component
Current openFDA PMA Record#
- Device
- PreveLeak Surgical Sealant
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P100030
- Supplement
- S007
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2017-08-25
- Decision code
- APPR
- Date received
- 2017-05-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes to the pH specification and the ratio of salts for the crosslinker solution component