ADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL
FDA premarket approval P960057/S001 · decided 1998-09-11
Approval details
- PMA number
- P960057
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL
- Generic name
- Inhibitor, peridural fibrosis (adhesion barrier)
- Applicant
- Wrightmedicaltechnologyinc
- Date received
- 1998-08-28
- Decision date
- 1998-09-11
- Days to decision
- 14 days
- Decision code
- OK30
- Product code
- MLQ
- Advisory committee
- Physical Medicine
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- The 30-day Notice requested that FDA review a change in the manufacturing process. A Vertrod Thermal Impulse Heat Sealer will be used in place of an Audion Future Jaw clamp pouch sealer to seal the Tyvek pouch containing the aluminum tube of ADCON(R)-L Adhesion Control Barrier Gel. This change does not affect the currently approved Tyvek seal integrity testing method or specification.
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