PMA P050011

Device
Adept Adhesion Reduction Solution
Applicant
Baxter Healthcare Corp
PMA number
P050011
Supplement
S008
Product code
MCN
Decision date
2024-08-23
Generic name
Barrier, absorbable, adhesion
Approval order statement
replacement of autoclave in the Terumo BCT Ltd., Ireland manufacturing facility

Current openFDA PMA Record#

Device
Adept Adhesion Reduction Solution
Applicant
Baxter Healthcare Corp
PMA number
P050011
Supplement
S009
Product code
MCN
Generic name
Barrier, absorbable, adhesion
Decision date
2024-08-23
Decision code
OK30
Date received
2024-07-26
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
replacement of autoclave in the Terumo BCT Ltd., Ireland manufacturing facility