LINX REFLUX MANAGEMENT SYSTEM
FDA premarket approval P100049/S011 · decided 2015-01-21
Approval details
- PMA number
- P100049
- Supplement
- S011
- 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
- 2014-10-27
- Decision date
- 2015-01-21
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- LEI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Cincinnati, OH
- Statement
- APPROVAL FOR MODIFICATIONS TO THE INTERNAL MAGNETS AND WIRE LINKS CONNECTING THE BEADS, AS WELL AS ASSOCIATED MODIFICATIONS TO THE LABELING, ALLOWING THE DEVICE TO BE MAGNETIC RESONANCE (MR) CONDITIONAL UP TO 1.5 TESLA.
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