BioGlue Surgical Adhesive
FDA premarket approval P010003/S035 · decided 2019-09-05
Approval details
- PMA number
- P010003
- Supplement
- S035
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BioGlue Surgical Adhesive
- Generic name
- Glue, surgical, arteries
- Applicant
- Cryolife, Inc.
- Date received
- 2019-04-22
- Decision date
- 2019-09-05
- Days to decision
- 136 days
- Decision code
- APPR
- Product code
- MUQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- Approval for a modification to the extraction method of the mixing and spreader tips for the Limulus Amebocyte Lysate (LAL) endotoxin testing, as well as modifications to the test method for LAL endotoxin testing.
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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 |