LINX REFLUX MANAGEMENT SYSTEM
FDA premarket approval P100049/S015 · decided 2016-03-02
Approval details
- PMA number
- P100049
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LINX REFLUX MANAGEMENT SYSTEM
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Applicant
- Torax Medical
- Date received
- 2015-12-08
- Decision date
- 2016-03-02
- Days to decision
- 85 days
- Decision code
- APPR
- Product code
- LEI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Cincinnati, OH
- Statement
- Approval for updating the labeling with safety and effectiveness data out to five (5) years for the pivotal trial cohort extended follow-up that has been completed and modify the Indications For Use.
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