PMA P100030S017
- Device
- Preveleak Surgical Sealant
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P100030
- Supplement
- S017
- Product code
- NBE
- Decision date
- 2023-04-28
- Classification
- Cardiovascular
- Generic name
- Sealant, polymerizing
- Approval order statement
- Alternative bacterial endotoxin testing methods for the Preveleak Surgical Sealant.
Current openFDA PMA Record#
- Device
- Preveleak Surgical Sealant
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P100030
- Supplement
- S017
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2023-04-28
- Decision code
- OK30
- Date received
- 2023-03-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternative bacterial endotoxin testing methods for the Preveleak Surgical Sealant.