LINX REFLUX MANAGEMENT SYSTEM
FDA premarket approval P100049/S019 · decided 2017-01-12
Approval details
- PMA number
- P100049
- Supplement
- S019
- 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
- 2016-12-15
- Decision date
- 2017-01-12
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LEI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Cincinnati, OH
- Statement
- Utilization of an additional, higher capacity laser welding system and to maintain 100% individual link length inspection conducted at final device inspection, but remove all in-process assembly weld link length inspections and the overall device length final inspection.
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