COHERA MEDICAL TISSUGLU SURGICAL ADHESIVE
FDA premarket approval P130023/S005 · decided 2017-07-27
Approval details
- PMA number
- P130023
- Supplement
- S005
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COHERA MEDICAL TISSUGLU SURGICAL ADHESIVE
- Generic name
- Tissue adhesive for internal use
- Applicant
- Cohera Medical, Inc.
- Date received
- 2017-01-26
- Decision date
- 2017-07-27
- Days to decision
- 182 days
- Decision code
- APPR
- Product code
- PJK
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- Approval for a modification to the TissuGlu® synthesis process where a small percentage of the stability reagents (sulfuric acid and DMSO stock solution) that are normally added at the end of the product synthesis process is instead added at the beginning of synthesis ("borrowed acid process").
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