ADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL
FDA premarket approval P960057 · decided 1998-05-27
Approval details
- PMA number
- P960057
- Trade name
- ADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL
- Generic name
- Inhibitor, peridural fibrosis (adhesion barrier)
- Applicant
- Wrightmedicaltechnologyinc
- Date received
- 1996-12-23
- Decision date
- 1998-05-27
- Days to decision
- 520 days
- Decision code
- APWD
- Product code
- MLQ
- Advisory committee
- Neurology
- Expedited review
- Yes
- Location
- Arlington, TN
- Statement
- Approval for ADCON(R)-L Adhesion Barrier Gel. This 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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