LINX REFLUX MANAGEMENT SYSTEM
FDA premarket approval P100049/S004 · decided 2013-03-07
Approval details
- PMA number
- P100049
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LINX REFLUX MANAGEMENT SYSTEM
- Generic name
- IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
- Applicant
- Torax Medical
- Date received
- 2012-06-19
- Decision date
- 2013-03-07
- Days to decision
- 261 days
- Decision code
- APPR
- Product code
- LEI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Cincinnati, OH
- Statement
- APPROVAL FOR A NEW ESOPHAGUS SIZING TOOL THAT WILL BE USED DURING THE IMPLANT PROCEDURE.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.