BIOGLUE SURGICAL ADHESIVE
FDA premarket approval P010003/S022 · decided 2016-05-04
Approval details
- PMA number
- P010003
- Supplement
- S022
- Supplement type
- 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
- 2016-04-04
- Decision date
- 2016-05-04
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MUQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Kennesaw, GA
- Statement
- Change to the frequency of the bioburden assessments from quarterly to annually for BioGlue Accessories that undergo Ethylene Oxide (EO) sterilization, a modification to the Limulus Amebocyte Lysate (LAL) test method for BioGlue to include agitation during the extraction process and change the dilution to test the BioGlue extract, and to eliminate the quarterly autoclave cycle verification and the quarterly issuance of Certificates of Completion for the autoclaves used in production and microbio
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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 |