PMA P100049S011

Device: LINX REFLUX MANAGEMENT SYSTEM
Applicant: Torax Medical
PMA number: P100049
Supplement: S011
Product code: LEI
Decision date: 2015-01-21
Classification: Implant, Anti-gastroesophageal Reflux
Generic name: IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE INTERNAL MAGNETS AND WIRE LINKS CONNECTING THE BEADS, AS WELL AS ASSOCIATED MODIFICATIONS TO THE LABELING, ALLOWING THE DEVICE TO BE MAGNETIC RESONANCE (MR) CONDITIONAL UP TO 1.5 TESLA.

Current openFDA PMA Record#

Device: LINX REFLUX MANAGEMENT SYSTEM
Applicant: Torax Medical
PMA number: P100049
Supplement: S011
Product code: LEI
Generic name: IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
Decision date: 2015-01-21
Decision code: APPR
Date received: 2014-10-27
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE INTERNAL MAGNETS AND WIRE LINKS CONNECTING THE BEADS, AS WELL AS ASSOCIATED MODIFICATIONS TO THE LABELING, ALLOWING THE DEVICE TO BE MAGNETIC RESONANCE (MR) CONDITIONAL UP TO 1.5 TESLA.