PMA P100030S014
- Device
- Preveleak Surgical Sealant - 1O-Pack Delivery Tips
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P100030
- Supplement
- S014
- Product code
- NBE
- Decision date
- 2020-12-02
- Generic name
- Sealant, polymerizing
- Approval order statement
- Updates to the labeling to reflect a change in ownership and other minor updates to conform with current labeling standards.
Current openFDA PMA Record#
- Device
- Preveleak Surgical Sealant - 1O-Pack Delivery Tips
- Applicant
- Baxter Healthcare Corporation
- PMA number
- P100030
- Supplement
- S014
- Product code
- NBE
- Generic name
- Sealant, polymerizing
- Decision date
- 2020-12-02
- Decision code
- APPR
- Date received
- 2020-09-14
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Updates to the labeling to reflect a change in ownership and other minor updates to conform with current labeling standards.