LINX Reflux Management System
FDA premarket approval P100049/S023 · decided 2018-09-06
Approval details
- PMA number
- P100049
- Supplement
- S023
- Supplement type
- 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
- 2018-08-22
- Decision date
- 2018-09-06
- Days to decision
- 15 days
- Decision code
- OK30
- Product code
- LEI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Cincinnati, OH
- Statement
- Integration of updated labeling, shipping, and distribution procedures.
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