LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM
FDA premarket approval P000008/S026 · decided 2011-12-09
Approval details
- PMA number
- P000008
- Supplement
- S026
- Supplement type
- Real-Time Process
- 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
- 2011-10-11
- Decision date
- 2011-12-09
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Eden Prairie, MN
- Statement
- APPROVAL FOR AN ALTERNATE HUB MATERIAL ON THE 3.5 INCH AND 2.0 INCH ACCESS PORT NEEDLES USED WITH THE LAP-BAND SYSTEM.
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