Linx Reflux Management System
FDA premarket approval P100049/S020 · decided 2018-01-29
Approval details
- PMA number
- P100049
- Supplement
- S020
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- Linx Reflux Management System
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Applicant
- Torax Medical
- Date received
- 2017-11-15
- Decision date
- 2018-01-29
- Days to decision
- 75 days
- Decision code
- APPR
- Product code
- LEI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Cincinnati, OH
- Statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
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