REALIZE ADJUSTABLE GASTRIC BANDS WITH INJECTION PORT AND APPLIER
FDA premarket approval P070009/S012 · decided 2011-03-31
Approval details
- PMA number
- P070009
- Supplement
- S012
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- REALIZE ADJUSTABLE GASTRIC BANDS WITH INJECTION PORT AND APPLIER
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Obtech Medical GmbH
- Date received
- 2011-02-08
- Decision date
- 2011-03-31
- Days to decision
- 51 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Zug
- Statement
- APPROVAL FOR THE USE OF AN ALTERNATE SUPPLIER FOR THE INJECTION MOLDING OF THE SEPTUM AND CONNECTOR SLEEVE COMPONENTS OF THE INJECTION PORT.
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