PMA P010003S028
- Device
- BioGlue Surgical Adhesive
- Applicant
- Cryolife, Inc.
- PMA number
- P010003
- Supplement
- S028
- Product code
- MUQ
- Decision date
- 2017-09-12
- Classification
- Glue, Surgical, Arteries
- Generic name
- Glue, surgical, arteries
- Approval order statement
- Removal of the EO gas weight parameter from CryoLife procedures.
Current openFDA PMA Record#
- Device
- BioGlue Surgical Adhesive
- Applicant
- Cryolife, Inc.
- PMA number
- P010003
- Supplement
- S028
- Product code
- MUQ
- Generic name
- Glue, surgical, arteries
- Decision date
- 2017-09-12
- Decision code
- OK30
- Date received
- 2017-08-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removal of the EO gas weight parameter from CryoLife procedures.