Ethicon Endo-Surgery Curved Adjustable Gastric Band with Sutureless Port and Applier; Ethicon Endo-Surgery Gastric Band
FDA premarket approval P070009/S016 · decided 2016-05-16
Approval details
- PMA number
- P070009
- Supplement
- S016
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Ethicon Endo-Surgery Curved Adjustable Gastric Band with Sutureless Port and Applier; Ethicon Endo-Surgery Gastric Band
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Obtech Medical GmbH
- Date received
- 2016-04-21
- Decision date
- 2016-05-16
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Zug
- Statement
- Approval for the trade name changes from REALIZE Adjustable Gastric Band-C with Injection Port and Applier to Ethicon Endo-Surgery Curved Adjustable Gastric Band with Sutureless Port and Applier, and REALIZE Injection Port and Applier to Ethicon Endo-Surgery Gastric Band Sutureless Port and Applier.
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