COHERA MEDICAL TISSUGLU
FDA premarket approval P130023 · decided 2015-02-03
Approval details
- PMA number
- P130023
- Trade name
- COHERA MEDICAL TISSUGLU
- Generic name
- Tissue adhesive for internal use
- Applicant
- Cohera Medical, Inc.
- Date received
- 2013-11-12
- Decision date
- 2015-02-03
- Days to decision
- 448 days
- Decision code
- APPR
- Product code
- PJK
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- APPROVAL FOR THE TISSUGLU® SURGICAL ADHESIVE. THIS DEVICE IS INDICATED FOR THE APPROXIMATION OF TISSUE LAYERS WHERE SUBCUTANEOUS DEAD SPACE EXISTS BETWEEN THE TISSUE PLANES IN ABDOMINOPLASTY.
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