PMA P960057S004

Device: ADCON-L ADHESION CONTROL IN A BARRIER GEL
Applicant: Wrightmedicaltechnologyinc
PMA number: P960057
Supplement: S004
Product code: MLQ
Decision date: 1999-08-11
Classification: Inhibitor, Peridural Fibrosis (adhesion Barrier)
Generic name: Inhibitor, peridural fibrosis (adhesion barrier)
Approval order statement: Approval for a patient brochure. The device is indicated for use during single level, posterior lumbar laminotomy procedures where nerve roots are exposed to inhibit postsurgical peridural fibrosis.

Current openFDA PMA Record#

Device: ADCON-L ADHESION CONTROL IN A BARRIER GEL
Applicant: Wrightmedicaltechnologyinc
PMA number: P960057
Supplement: S004
Product code: MLQ
Generic name: Inhibitor, peridural fibrosis (adhesion barrier)
Decision date: 1999-08-11
Decision code: APPR
Date received: 1999-02-11
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for a patient brochure. The device is indicated for use during single level, posterior lumbar laminotomy procedures where nerve roots are exposed to inhibit postsurgical peridural fibrosis.