BIOENTERICS LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
FDA premarket approval P000008/S005 · decided 2003-01-08
Approval details
- PMA number
- P000008
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIOENTERICS LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Medtimo, Inc.
- Date received
- 2002-11-21
- Decision date
- 2003-01-08
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Eden Prairie, MN
- Statement
- APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT INAMED CORPORATION, SANTA BARBARA, CALIFORNIA.
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