PMA P010003S023

Device: BIOGLUE SURGICAL ADHESIVE
Applicant: Cryolife, Inc.
PMA number: P010003
Supplement: S023
Product code: MUQ
Decision date: 2017-02-10
Classification: Glue, Surgical, Arteries
Generic name: Glue, surgical, arteries
Approval order statement: Approval for changes in the molding parameters used in the manufacturing of the 5 mL BioGlue container, as well as the addition of a new resin for molding portions of all BioGlue containers used with the BioGlue Surgical Adhesive.

Current openFDA PMA Record#

Device: BIOGLUE SURGICAL ADHESIVE
Applicant: Cryolife, Inc.
PMA number: P010003
Supplement: S023
Product code: MUQ
Generic name: Glue, surgical, arteries
Decision date: 2017-02-10
Decision code: APPR
Date received: 2016-04-07
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for changes in the molding parameters used in the manufacturing of the 5 mL BioGlue container, as well as the addition of a new resin for molding portions of all BioGlue containers used with the BioGlue Surgical Adhesive.