ADCON(R)-L ADHESION CONTROL IN A BARRIER GEL
FDA premarket approval P960057/S011 · decided 2000-09-27
Approval details
- PMA number
- P960057
- Supplement
- S011
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ADCON(R)-L ADHESION CONTROL IN A BARRIER GEL
- Generic name
- Inhibitor, peridural fibrosis (adhesion barrier)
- Applicant
- Wrightmedicaltechnologyinc
- Date received
- 2000-06-26
- Decision date
- 2000-09-27
- Days to decision
- 93 days
- Decision code
- APPR
- Product code
- MLQ
- Advisory committee
- Physical Medicine
- Expedited review
- No
- Location
- Arlington, TN
- 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.
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