LINX REFLUX MANAGEMENT SYSTEM
FDA premarket approval P100049/S010 · decided 2014-07-22
Approval details
- PMA number
- P100049
- Supplement
- S010
- Supplement type
- Special (Immediate Track)
- Trade name
- LINX REFLUX MANAGEMENT SYSTEM
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Applicant
- Torax Medical
- Date received
- 2014-06-23
- Decision date
- 2014-07-22
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LEI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Cincinnati, OH
- Statement
- APPROVAL FOR LABELING ALTERATIONS INCLUDING ADVERSE EVENT INFORMATION ABOUT EROSION OF THE LINX DEVICE, CLARIFICATIONS OR CONTRAINDICATIONS REGARDING NICKEL, WARNINGS REGARDING STORAGE AND USE ABOVE 60 DEGREES C, ADDITIONAL POTENTIAL RISK OF SALIVA/MUCUS BUILD-UP, AND DIRECTIONS WHICH ADD THE REMOVAL OF SUTURES AFTER THE CLASP ENDS ARE FULLY ENGAGED.
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