ADCON-L ADHESION CONTROL IN A BARRIER GEL
FDA premarket approval P960057/S006 · decided 1999-04-21
Approval details
- PMA number
- P960057
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ADCON-L ADHESION CONTROL IN A BARRIER GEL
- Generic name
- Inhibitor, peridural fibrosis (adhesion barrier)
- Applicant
- Wrightmedicaltechnologyinc
- Date received
- 1999-03-12
- Decision date
- 1999-04-21
- Days to decision
- 40 days
- Decision code
- APPR
- Product code
- MLQ
- Advisory committee
- Physical Medicine
- Expedited review
- No
- Location
- Arlington, TN
- 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.
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