REALIZE ADJUSTABLE GASTRIC BAND WITH INJECTION PORT & APPLIER/REALIZE ADJUSTABLE GASTRIC BAND-C
FDA premarket approval P070009/S008 · decided 2010-07-30
Approval details
- PMA number
- P070009
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- REALIZE ADJUSTABLE GASTRIC BAND WITH INJECTION PORT & APPLIER/REALIZE ADJUSTABLE GASTRIC BAND-C
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Obtech Medical GmbH
- Date received
- 2010-06-07
- Decision date
- 2010-07-30
- Days to decision
- 53 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Zug
- Statement
- APPROVAL FOR A DEVICE CHANGE TO ADD A SILICONE ADHESIVE TO BOND THE STRAIN RELIEF SLEEVE AND THE LOCKING CONNECTOR COMPONENTS OF THE INJECTION PORT.
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