LINX REFLUX MANAGEMENT SYSTEM
FDA premarket approval P100049/S006 · decided 2013-12-19
Approval details
- PMA number
- P100049
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LINX REFLUX MANAGEMENT SYSTEM
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Applicant
- Torax Medical
- Date received
- 2013-05-07
- Decision date
- 2013-12-19
- Days to decision
- 226 days
- Decision code
- APPR
- Product code
- LEI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Cincinnati, OH
- Statement
- APPROVAL FOR AN UPDATE TO THE LABELING FOR THE LINX DEVICE REGARDING EXPOSURE TO MRI SCANS.
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