PMA P100049S002

Device
LINX REFLUX MANAGEMENT SYSTEM
Applicant
Torax Medical
PMA number
P100049
Supplement
S002
Product code
LEI
Decision date
2012-06-22
Generic name
IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.

Current openFDA PMA Record#

Device
LINX REFLUX MANAGEMENT SYSTEM
Applicant
Torax Medical
PMA number
P100049
Supplement
S002
Product code
LEI
Generic name
IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX
Decision date
2012-06-22
Decision code
APPR
Date received
2012-04-23
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol - OSB
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.