PMA P070009

Device: ETHICON ENDO-SURGERY CURVED ADJUSTABLE GASTRIC WITH SUTURELESS PORT AND APPLIER; ETHICON ENDO-SURGERY GASTRIC BAND SUTUR
Applicant: Obtech Medical GmbH
PMA number: P070009
Supplement: S017
Product code: LTI
Decision date: 2016-10-11
Generic name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Approval order statement: Approval for changes to the device labeling made as a result of the approval of the 5 year Post-Approval Study.

Current openFDA PMA Record#

Device: ETHICON ENDO-SURGERY CURVED ADJUSTABLE GASTRIC WITH SUTURELESS PORT AND APPLIER; ETHICON ENDO-SURGERY GASTRIC BAND SUTUR
Applicant: Obtech Medical GmbH
PMA number: P070009
Supplement: S017
Product code: LTI
Generic name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Decision date: 2016-10-11
Decision code: APPR
Date received: 2016-06-21
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: Approval for changes to the device labeling made as a result of the approval of the 5 year Post-Approval Study.