COHERA MEDICAL TISSUGLU SURGICAL ADHESIVE
FDA premarket approval P130023/S003 · decided 2017-02-01
Approval details
- PMA number
- P130023
- Supplement
- S003
- Supplement type
- 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
- 2016-05-09
- Decision date
- 2017-02-01
- Days to decision
- 268 days
- Decision code
- OK30
- Product code
- PJK
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- Relocation of the lab equipment where quality control release testing of the TissuGlu Surgical Adhesive cartridge lots is conducted.
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