ADCON-L ADHESION CONTROL IN A BARRIER GEL
FDA premarket approval P960057/S004 · decided 1999-08-11
Approval details
- PMA number
- P960057
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- 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
- 1999-02-11
- Decision date
- 1999-08-11
- Days to decision
- 181 days
- Decision code
- APPR
- Product code
- MLQ
- Advisory committee
- Physical Medicine
- Expedited review
- No
- Location
- Arlington, TN
- 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.
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