LINX Reflux Management System
FDA premarket approval P100049/S035 · decided 2023-12-14
Approval details
- PMA number
- P100049
- Supplement
- S035
- 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
- 2023-11-14
- Decision date
- 2023-12-14
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LEI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Cincinnati, OH
- Statement
- for the change of an internal inspection process to an equivalent inspection process at their magnet component supplier.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.