PMA P010003S022

Device: BIOGLUE SURGICAL ADHESIVE
Applicant: Cryolife, Inc.
PMA number: P010003
Supplement: S022
Product code: MUQ
Decision date: 2016-05-04
Classification: Glue, Surgical, Arteries
Generic name: Glue, surgical, arteries
Approval order statement: Change to the frequency of the bioburden assessments from quarterly to annually for BioGlue Accessories that undergo Ethylene Oxide (EO) sterilization, a modification to the Limulus Amebocyte Lysate (LAL) test method for BioGlue to include agitation during the extraction process and change the dilution to test the BioGlue extract, and to eliminate the quarterly autoclave cycle verification and the quarterly issuance of Certificates of Completion for the autoclaves used in production and microbiology.

Current openFDA PMA Record#

Device: BIOGLUE SURGICAL ADHESIVE
Applicant: Cryolife, Inc.
PMA number: P010003
Supplement: S022
Product code: MUQ
Generic name: Glue, surgical, arteries
Decision date: 2016-05-04
Decision code: OK30
Date received: 2016-04-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to the frequency of the bioburden assessments from quarterly to annually for BioGlue Accessories that undergo Ethylene Oxide (EO) sterilization, a modification to the Limulus Amebocyte Lysate (LAL) test method for BioGlue to include agitation during the extraction process and change the dilution to test the BioGlue extract, and to eliminate the quarterly autoclave cycle verification and the quarterly issuance of Certificates of Completion for the autoclaves used in production and microbiology.