BIOENTERICS LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
FDA premarket approval P000008/S006 · decided 2003-12-05
Approval details
- PMA number
- P000008
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BIOENTERICS LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Medtimo, Inc.
- Date received
- 2003-06-05
- Decision date
- 2003-12-05
- Days to decision
- 183 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Eden Prairie, MN
- Statement
- APPROVAL FOR AN ADDITIONAL SIZE (11.0 CM) FOR THE LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VANGUARD LAP-BAND.
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