- Device
- BioGlue Surgical Adhesive
- Applicant
- Cryolife, Inc.
- PMA number
- P010003
- Supplement
- S037
- Product code
- MUQ
- Generic name
- Glue, surgical, arteries
- Decision date
- 2019-12-20
- Decision code
- OK30
- Date received
- 2019-11-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- 1) An alternate supplier for a device component; 2) a change in quality control sampling of another device component; and 3) a change in the 5mL syringe plungers dimension lower tolerance.