REALIZE ADJUSTABLE GASTRIC BAND WITH INJECTION PORT & APPLIER
FDA premarket approval P070009/S009 · decided 2010-06-04
Approval details
- PMA number
- P070009
- Supplement
- S009
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- REALIZE ADJUSTABLE GASTRIC BAND WITH INJECTION PORT & APPLIER
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Obtech Medical GmbH
- Date received
- 2010-05-07
- Decision date
- 2010-06-04
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Zug
- Statement
- APPROVAL FOR MINOR CHANGES TO THE LABELING.
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