LINX Reflux Management System
FDA premarket approval P100049/S027 · decided 2020-06-29
Approval details
- PMA number
- P100049
- Supplement
- S027
- Supplement type
- 135 Review Track For 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
- 2019-09-17
- Decision date
- 2020-06-29
- Days to decision
- 286 days
- Decision code
- APPR
- Product code
- LEI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Cincinnati, OH
- Statement
- adding a second Hardwell Controlled Environmental Area (CEA).
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