PMA P010003S033
- Device
- BioGlue Surgical Adhesive
- Applicant
- Cryolife, Inc.
- Product code
- MUQ
- Decision date
- 2019-11-21
- Generic name
- Glue, surgical, arteries
- Approval order statement
- Approval for changes to the resin, design and shelf-life of the Spreader Applicator Tips.
Current openFDA PMA Record#
- Device
- BioGlue Surgical Adhesive
- Applicant
- Cryolife, Inc.
- PMA number
- P010003
- Supplement
- S033
- Product code
- MUQ
- Generic name
- Glue, surgical, arteries
- Decision date
- 2019-11-21
- Decision code
- APPR
- Date received
- 2019-03-29
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes to the resin, design and shelf-life of the Spreader Applicator Tips.