PMA P010003S019

Device
BIOGLUE SURGICAL ADHESIVE
Applicant
Cryolife, Inc.
PMA number
P010003
Supplement
S019
Product code
MUQ
Decision date
2015-09-24
Classification
Glue, Surgical, Arteries
Generic name
Glue, surgical, arteries
Approval order statement
CHANGE IN THE METHOD TO DETERMINE PROTEIN CONCENTRATION.

Current openFDA PMA Record#

Device
BIOGLUE SURGICAL ADHESIVE
Applicant
Cryolife, Inc.
PMA number
P010003
Supplement
S019
Product code
MUQ
Generic name
Glue, surgical, arteries
Decision date
2015-09-24
Decision code
OK30
Date received
2015-08-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE IN THE METHOD TO DETERMINE PROTEIN CONCENTRATION.