PMA P010003S031
- Device
- BioGlue Surgical Adhesive
- Applicant
- Cryolife, Inc.
- PMA number
- P010003
- Supplement
- S031
- Product code
- MUQ
- Decision date
- 2018-11-01
- Classification
- Glue, Surgical, Arteries
- Generic name
- Glue, surgical, arteries
- Approval order statement
- Approval for changes to the instructions for use.
Current openFDA PMA Record#
- Device
- BioGlue Surgical Adhesive
- Applicant
- Cryolife, Inc.
- PMA number
- P010003
- Supplement
- S031
- Product code
- MUQ
- Generic name
- Glue, surgical, arteries
- Decision date
- 2018-11-01
- Decision code
- APPR
- Date received
- 2018-10-02
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for changes to the instructions for use.