ADCON -L ADHESION CONTROL IN A BARRIER GEL
FDA premarket approval P960057/S003 · decided 1999-01-14
Approval details
- PMA number
- P960057
- Supplement
- S003
- Supplement type
- 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
- 1998-12-21
- Decision date
- 1999-01-14
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- MLQ
- Advisory committee
- Physical Medicine
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- The 30-Day Notice requested a change in the water temperature, mixing time and mixing speed used in the manufacturing process for the Adcon(R)-L Adhesion Control Barrier Gel. The proposed modifications are designed to increase the efficiency of the gel manufacturing process.
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