PMA P010003S030
- Device
- BioGlue Surgical Adhesive
- Applicant
- Cryolife, Inc.
- PMA number
- P010003
- Supplement
- S030
- Product code
- MUQ
- Decision date
- 2018-06-25
- Classification
- Glue, Surgical, Arteries
- Generic name
- Glue, surgical, arteries
- Approval order statement
- Change in the sterilization dosimetry system for BioGlue Surgical Adhesive.
Current openFDA PMA Record#
- Device
- BioGlue Surgical Adhesive
- Applicant
- Cryolife, Inc.
- PMA number
- P010003
- Supplement
- S030
- Product code
- MUQ
- Generic name
- Glue, surgical, arteries
- Decision date
- 2018-06-25
- Decision code
- OK30
- Date received
- 2018-05-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the sterilization dosimetry system for BioGlue Surgical Adhesive.