PMA P010003S040
- Device
- BioGlue Surgical Adhesive
- Applicant
- Cryolife, Inc.
- PMA number
- P010003
- Supplement
- S040
- Product code
- MUQ
- Decision date
- 2022-05-25
- Generic name
- Glue, surgical, arteries
- Approval order statement
- Alternative irradiation box and configuration for shipping product, and a new supplier for the strong ammonium solution.
Current openFDA PMA Record#
- Device
- BioGlue Surgical Adhesive
- Applicant
- Cryolife, Inc.
- PMA number
- P010003
- Supplement
- S040
- Product code
- MUQ
- Generic name
- Glue, surgical, arteries
- Decision date
- 2022-05-25
- Decision code
- OK30
- Date received
- 2022-04-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternative irradiation box and configuration for shipping product, and a new supplier for the strong ammonium solution.