PMA P010003S027
- Device
- BioGlue Surgical Adhesive
- Applicant
- Cryolife, Inc.
- PMA number
- P010003
- Supplement
- S027
- Product code
- MUQ
- Decision date
- 2017-08-21
- Classification
- Glue, Surgical, Arteries
- Generic name
- Glue, surgical, arteries
- Approval order statement
- Approval to establish a minimum seal width specification for the outer-most pouches of BioGlue and BioGlue accessories.
Current openFDA PMA Record#
- Device
- BioGlue Surgical Adhesive
- Applicant
- Cryolife, Inc.
- PMA number
- P010003
- Supplement
- S027
- Product code
- MUQ
- Generic name
- Glue, surgical, arteries
- Decision date
- 2017-08-21
- Decision code
- APPR
- Date received
- 2017-07-24
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to establish a minimum seal width specification for the outer-most pouches of BioGlue and BioGlue accessories.