PMA P130023S003
- Device
- COHERA MEDICAL TISSUGLU SURGICAL ADHESIVE
- Applicant
- Cohera Medical, Inc.
- PMA number
- P130023
- Supplement
- S003
- Product code
- PJK
- Decision date
- 2017-02-01
- Generic name
- Tissue adhesive for internal use
- Approval order statement
- Relocation of the lab equipment where quality control release testing of the TissuGlu Surgical Adhesive cartridge lots is conducted.
Current openFDA PMA Record#
- Device
- COHERA MEDICAL TISSUGLU SURGICAL ADHESIVE
- Applicant
- Cohera Medical, Inc.
- PMA number
- P130023
- Supplement
- S003
- Product code
- PJK
- Generic name
- Tissue adhesive for internal use
- Decision date
- 2017-02-01
- Decision code
- OK30
- Date received
- 2016-05-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Relocation of the lab equipment where quality control release testing of the TissuGlu Surgical Adhesive cartridge lots is conducted.