LINX Reflux Management System
FDA premarket approval P100049/S033 · decided 2022-10-04
Approval details
- PMA number
- P100049
- Supplement
- S033
- Supplement type
- Normal 180 Day Track
- 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
- 2022-04-08
- Decision date
- 2022-10-04
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- LEI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Cincinnati, OH
- Statement
- Approval for the following labeling updates: 1) inclusion of final post-approval study results; 2) addition of a precaution based on RELIEF study results; 3) addition of swallow-induced syncope to the list of adverse events; and 4) revised registered/trademark status.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.