- Device
- BioGlue® Surgical Adhesive
- Applicant
- Cryolife, Inc.
- PMA number
- P010003
- Supplement
- S042
- Product code
- MUQ
- Generic name
- Glue, surgical, arteries
- Decision date
- 2025-03-18
- Decision code
- APPR
- Date received
- 2023-12-18
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the addition of:• STERIS, located at 1800 Industrial Drive, Libertyville, IL 60048, FEI #1450662, as an alternate sterilization site for the BioGlue Surgical Adhesive syringes• Medline Industries – Northpoint Services, located at 1160 S. Northpoint Blvd, Waukegan, IL 60085, FEI #1000514656, as an alternate sterilization site the Syringe Extender Tips accessory