PMA P960057S006

Device: ADCON-L ADHESION CONTROL IN A BARRIER GEL
Applicant: Wrightmedicaltechnologyinc
PMA number: P960057
Supplement: S006
Product code: MLQ
Decision date: 1999-04-21
Classification: Inhibitor, Peridural Fibrosis (adhesion Barrier)
Generic name: Inhibitor, peridural fibrosis (adhesion barrier)
Approval order statement: Approval for extending the expiration dating for ADCON-L Adhesion Control in a Barrier Gel syring configurations from 6 months to 12 months. The device is indicated for use during single level, posterior lumbar laminectomy or 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: S006
Product code: MLQ
Generic name: Inhibitor, peridural fibrosis (adhesion barrier)
Decision date: 1999-04-21
Decision code: APPR
Date received: 1999-03-12
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for extending the expiration dating for ADCON-L Adhesion Control in a Barrier Gel syring configurations from 6 months to 12 months. The device is indicated for use during single level, posterior lumbar laminectomy or laminotomy procedures where nerve roots are exposed to inhibit postsurgical peridural fibrosis.