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PMA P010003S035

Device
BioGlue Surgical Adhesive
Applicant
Cryolife, Inc.
Product code
MUQ
Decision date
2019-09-05
Generic name
Glue, surgical, arteries
Approval order statement
Approval for a modification to the extraction method of the mixing and spreader tips for the Limulus Amebocyte Lysate (LAL) endotoxin testing, as well as modifications to the test method for LAL endotoxin testing.

Current openFDA PMA Record#

Device
BioGlue Surgical Adhesive
Applicant
Cryolife, Inc.
PMA number
P010003
Supplement
S035
Product code
MUQ
Generic name
Glue, surgical, arteries
Decision date
2019-09-05
Decision code
APPR
Date received
2019-04-22
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for a modification to the extraction method of the mixing and spreader tips for the Limulus Amebocyte Lysate (LAL) endotoxin testing, as well as modifications to the test method for LAL endotoxin testing.