PMA P010003S041
- Device
- BioGlue® Surgical Adhesive
- Applicant
- Cryolife, Inc.
- PMA number
- P010003
- Supplement
- S041
- Product code
- MUQ
- Decision date
- 2023-10-20
- Classification
- Cardiovascular
- Generic name
- Glue, surgical, arteries
- Approval order statement
- Approval for an additional caution statement regarding use of the device in aortic dissection surgery and other minor updates to the Instructions for Use.
Current openFDA PMA Record#
- Device
- BioGlue® Surgical Adhesive
- Applicant
- Cryolife, Inc.
- PMA number
- P010003
- Supplement
- S041
- Product code
- MUQ
- Generic name
- Glue, surgical, arteries
- Decision date
- 2023-10-20
- Decision code
- APPR
- Date received
- 2023-09-20
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for an additional caution statement regarding use of the device in aortic dissection surgery and other minor updates to the Instructions for Use.