ADCON -L ADHESION CONTROL IN A BARRIER GEL
FDA premarket approval P960057/S002 · decided 1998-11-25
Approval details
- PMA number
- P960057
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ADCON -L ADHESION CONTROL IN A BARRIER GEL
- Generic name
- Inhibitor, peridural fibrosis (adhesion barrier)
- Applicant
- Wrightmedicaltechnologyinc
- Date received
- 1998-11-03
- Decision date
- 1998-11-25
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- MLQ
- Advisory committee
- Physical Medicine
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Approval for a change in ADCON-L kit packaging configuration, i.e., replacing the aluminum tube with a polypropylene syringe, and replacing the PVC application with a polypropylene applicator.
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