PMA P010003

Device: BioGlue® Surgical Adhesive
Applicant: Cryolife, Inc.
PMA number: P010003
Supplement: S040
Product code: MUQ
Decision date: 2026-07-15
Generic name: Glue, surgical, arteries
Approval order statement: approval for transferring the 2 mL BioGlue Surgical Adhesive fill from the currently approved 5 mL syringe body to the larger 10 mL syringe body and requested to extend the shelf life from 21 to 24 months for the 2 mL configuration.

Current openFDA PMA Record#

Device: BioGlue® Surgical Adhesive
Applicant: Cryolife, Inc.
PMA number: P010003
Supplement: S043
Product code: MUQ
Generic name: Glue, surgical, arteries
Decision date: 2026-07-15
Decision code: APPR
Date received: 2026-04-15
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for transferring the 2 mL BioGlue Surgical Adhesive fill from the currently approved 5 mL syringe body to the larger 10 mL syringe body and requested to extend the shelf life from 21 to 24 months for the 2 mL configuration.