ADCON-L ADHESION CONTROL IN A BARRIER GEL
FDA premarket approval P960057/S005 · decided 1999-03-18
Approval details
- PMA number
- P960057
- Supplement
- S005
- Supplement type
- 135 Review Track For 30-Day Notice
- 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
- 1999-02-19
- Decision date
- 1999-03-18
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MLQ
- Advisory committee
- Physical Medicine
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Accepted for an eight-day holding period for filled syringes prior to sterilization.
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