PMA P010003S038
- Device
- BioGlue Surgical Adhesive
- Applicant
- Cryolife, Inc.
- PMA number
- P010003
- Supplement
- S038
- Product code
- MUQ
- Decision date
- 2021-07-23
- Generic name
- Glue, surgical, arteries
- Approval order statement
- Change LAL extraction methods for the syringe, extender tips, and delivery tip extensions, and implementation of electronic IFU.
Current openFDA PMA Record#
- Device
- BioGlue Surgical Adhesive
- Applicant
- Cryolife, Inc.
- PMA number
- P010003
- Supplement
- S038
- Product code
- MUQ
- Generic name
- Glue, surgical, arteries
- Decision date
- 2021-07-23
- Decision code
- OK30
- Date received
- 2021-06-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change LAL extraction methods for the syringe, extender tips, and delivery tip extensions, and implementation of electronic IFU.