PMA P960057S002

Device: ADCON -L ADHESION CONTROL IN A BARRIER GEL
Applicant: Wrightmedicaltechnologyinc
PMA number: P960057
Supplement: S002
Product code: MLQ
Decision date: 1998-11-25
Classification: Inhibitor, Peridural Fibrosis (adhesion Barrier)
Generic name: Inhibitor, peridural fibrosis (adhesion barrier)
Approval order statement: Approval for a change in ADCON-L kit packaging configuration, i.e., replacing the aluminum tube with a polypropylene syringe, and replacing the PVC application with a polypropylene applicator.

Current openFDA PMA Record#

Device: ADCON -L ADHESION CONTROL IN A BARRIER GEL
Applicant: Wrightmedicaltechnologyinc
PMA number: P960057
Supplement: S002
Product code: MLQ
Generic name: Inhibitor, peridural fibrosis (adhesion barrier)
Decision date: 1998-11-25
Decision code: APPR
Date received: 1998-11-03
Supplement type: Real-Time Process
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a change in ADCON-L kit packaging configuration, i.e., replacing the aluminum tube with a polypropylene syringe, and replacing the PVC application with a polypropylene applicator.