- Device
- Ethicon Endo-Surgery Curved Adjustable Gastric Band with Sutureless Port and Applier; Ethicon Endo-Surgery Gastric Band
- Applicant
- Obtech Medical GmbH
- PMA number
- P070009
- Supplement
- S016
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2016-05-16
- Decision code
- APPR
- Date received
- 2016-04-21
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order 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.