LINX REFLUX MANAGEMENT SYSTEM
FDA premarket approval P100049/S012 · decided 2015-04-21
Approval details
- PMA number
- P100049
- Supplement
- S012
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LINX REFLUX MANAGEMENT SYSTEM
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Applicant
- Torax Medical
- Date received
- 2015-03-25
- Decision date
- 2015-04-21
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LEI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Cincinnati, OH
- Statement
- 1) UTILIZATION OF AN IN-HOUSE LASER WELDING SYSTEM;2) UTILIZATION OF IN-HOUSE HERMETICITY TESTING SYSTEMS;3) UTILIZATION OF AN IN-HOUSE WIRE CUTTING PROCESS;4) UTILIZATION OF AN IN-HOUSE PNEUMATIC WIRE LINK BENDING PROCESS; AND5) MODIFICATION OF AN INCOMING INSPECTION ACCEPTANCE CRITERION FOR ONE OF THE MAGNET TYPES.
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