PMA P010003S029
- Device
- BioGlue Surgical Adhesive
- Applicant
- Cryolife, Inc.
- PMA number
- P010003
- Supplement
- S029
- Product code
- MUQ
- Decision date
- 2018-01-03
- Classification
- Glue, Surgical, Arteries
- Generic name
- Glue, surgical, arteries
- Approval order statement
- Implement use of an additional resin in the manufacture of the mixing tip of the BioGlue Surgical Adhesive.
Current openFDA PMA Record#
- Device
- BioGlue Surgical Adhesive
- Applicant
- Cryolife, Inc.
- PMA number
- P010003
- Supplement
- S029
- Product code
- MUQ
- Generic name
- Glue, surgical, arteries
- Decision date
- 2018-01-03
- Decision code
- OK30
- Date received
- 2017-12-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement use of an additional resin in the manufacture of the mixing tip of the BioGlue Surgical Adhesive.