LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM
FDA premarket approval P000008/S014 · decided 2009-01-16
Approval details
- PMA number
- P000008
- Supplement
- S014
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Medtimo, Inc.
- Date received
- 2008-12-18
- Decision date
- 2009-01-16
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Eden Prairie, MN
- Statement
- APPROVAL FOR MODIFYING THE LABELING TO IDENTIFY THE ¿PARS FLACCIDA¿ TECHNIQUE AS THE RECOMMENDED TECHNIQUE TO USE DURING SURGICAL PLACEMENT OF THE DEVICE.
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