PMA P010003S036
- Device
- BioGlue Surgical Adhesive
- Applicant
- Cryolife, Inc.
- PMA number
- P010003
- Supplement
- S036
- Product code
- MUQ
- Decision date
- 2019-08-14
- Classification
- Glue, Surgical, Arteries
- Generic name
- Glue, surgical, arteries
- Approval order statement
- Change to the in-process incoming inspection of pouched, irradiated BioGlue syringes.
Current openFDA PMA Record#
- Device
- BioGlue Surgical Adhesive
- Applicant
- Cryolife, Inc.
- PMA number
- P010003
- Supplement
- S036
- Product code
- MUQ
- Generic name
- Glue, surgical, arteries
- Decision date
- 2019-08-14
- Decision code
- OK30
- Date received
- 2019-07-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the in-process incoming inspection of pouched, irradiated BioGlue syringes.