ETHICON ENDO-SURGERY CURVED ADJUSTABLE GASTRIC WITH SUTURELESS PORT AND APPLIER; ETHICON ENDO-SURGERY GASTRIC BAND SUTUR
FDA premarket approval P070009/S017 · decided 2016-10-11
Approval details
- PMA number
- P070009
- Supplement
- S017
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- ETHICON ENDO-SURGERY CURVED ADJUSTABLE GASTRIC WITH SUTURELESS PORT AND APPLIER; ETHICON ENDO-SURGERY GASTRIC BAND SUTUR
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Obtech Medical GmbH
- Date received
- 2016-06-21
- Decision date
- 2016-10-11
- Days to decision
- 112 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Zug
- Statement
- Approval for changes to the device labeling made as a result of the approval of the 5 year Post-Approval Study.
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