PMA P100030S015
- Device
- PREVELEAK Surgical Sealant
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P100030
- Supplement
- S015
- Product code
- NBE
- Decision date
- 2021-07-27
- Generic name
- Sealant, polymerizing
- Approval order statement
- Change in location for the quality control testing performed on the PreveLeak, from the Baxter Mountain View to Baxter Hayward facilities.
Current openFDA PMA Record#
- Device
- PREVELEAK Surgical Sealant
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P100030
- Supplement
- S015
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2021-07-27
- Decision code
- OK30
- Date received
- 2021-06-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in location for the quality control testing performed on the PreveLeak, from the Baxter Mountain View to Baxter Hayward facilities.