PMA P130023S002

Device: COHERA MEDICAL TISSUEGLU SURGICAL ADHESIVE
Applicant: Cohera Medical, Inc.
PMA number: P130023
Supplement: S002
Product code: PJK
Decision date: 2017-06-23
Generic name: Tissue adhesive for internal use
Approval order 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.

Current openFDA PMA Record#

Device: COHERA MEDICAL TISSUEGLU SURGICAL ADHESIVE
Applicant: Cohera Medical, Inc.
PMA number: P130023
Supplement: S002
Product code: PJK
Generic name: Tissue adhesive for internal use
Decision date: 2017-06-23
Decision code: APPR
Date received: 2016-02-02
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order 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.