PMA P960057

Device: ADCON(R)-L ADHESION CONTROL IN A BARRIER GEL
Applicant: Wrightmedicaltechnologyinc
PMA number: P960057
Supplement: S011
Product code: MLQ
Decision date: 2000-09-27
Classification: Inhibitor, Peridural Fibrosis (adhesion Barrier)
Generic name: Inhibitor, peridural fibrosis (adhesion barrier)
Approval order statement: APPROVAL FOR MODIFICATIONS TO PROCEDURES USED FOR THE MANUFACTURE AND TESTING OF THE DEVICE. 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(R)-L ADHESION CONTROL IN A BARRIER GEL
Applicant: Wrightmedicaltechnologyinc
PMA number: P960057
Supplement: S011
Product code: MLQ
Generic name: Inhibitor, peridural fibrosis (adhesion barrier)
Decision date: 2000-09-27
Decision code: APPR
Date received: 2000-06-26
Supplement type: Special (Immediate Track)
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR MODIFICATIONS TO PROCEDURES USED FOR THE MANUFACTURE AND TESTING OF THE DEVICE. 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.