BioGlue® Surgical Adhesive
FDA premarket approval P010003/S043 · decided 2026-07-15
Approval details
- PMA number
- P010003
- Supplement
- S043
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BioGlue® Surgical Adhesive
- Generic name
- Glue, surgical, arteries
- Applicant
- Cryolife, Inc.
- Date received
- 2026-04-15
- Decision date
- 2026-07-15
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- MUQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Kennesaw, GA
- 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.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| PhotoFix Decellularized Bovine Pericardium (K183635) | Cryolife, Inc. | 2019-02-14 |
| PhotoFix Decellularized Bovine Pericardium (K172085) | Cryolife, Inc. | 2017-12-04 |
| PhotoFix Decellularized Bovine Pericardium (K162506) | Cryolife, Inc. | 2017-03-09 |
| PERCLOT TOPICAL (K132105) | Cryolife, Inc. | 2014-04-03 |
| PROPATCH SOFT TISSUE REPAIR MATRIX (K110581) | Cryolife, Inc. | 2012-01-10 |
| PROPATCH SOFT TISSUE REPAIR MATRIX (K101587) | Cryolife, Inc. | 2010-09-16 |
| CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH (K101866) | Cryolife, Inc. | 2010-07-23 |
| CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT) (K092021) | Cryolife, Inc. | 2010-05-25 |