PMA P010003S039
- Device
- BioGlue® Surgical Adhesive
- Applicant
- Cryolife, Inc.
- PMA number
- P010003
- Supplement
- S039
- Product code
- MUQ
- Decision date
- 2021-12-09
- Generic name
- Glue, surgical, arteries
- Approval order statement
- Changes to the resin used to manufacture a portion of the syringe extender tips and a reduction in the shelf life of the finished device.
Current openFDA PMA Record#
- Device
- BioGlue® Surgical Adhesive
- Applicant
- Cryolife, Inc.
- PMA number
- P010003
- Supplement
- S039
- Product code
- MUQ
- Generic name
- Glue, surgical, arteries
- Decision date
- 2021-12-09
- Decision code
- OK30
- Date received
- 2021-11-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the resin used to manufacture a portion of the syringe extender tips and a reduction in the shelf life of the finished device.