COHERA MEDICAL TISSUEGLU SURGICAL ADHESIVE
FDA premarket approval P130023/S002 · decided 2017-06-23
Approval details
- PMA number
- P130023
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- COHERA MEDICAL TISSUEGLU SURGICAL ADHESIVE
- Generic name
- Tissue adhesive for internal use
- Applicant
- Cohera Medical, Inc.
- Date received
- 2016-02-02
- Decision date
- 2017-06-23
- Days to decision
- 507 days
- Decision code
- APPR
- Product code
- PJK
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- Approval for a manufacturing site located at Ximedica LLC, 55 Dupont Drive, Providence, Rhode Island, as a facility for cartridge filling, device assembly, packaging, management of sterilization, and final product release.
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