LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM
FDA premarket approval P000008/S013 · decided 2008-11-25
Approval details
- PMA number
- P000008
- Supplement
- S013
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Medtimo, Inc.
- Date received
- 2008-04-07
- Decision date
- 2008-11-25
- Days to decision
- 232 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Eden Prairie, MN
- Statement
- APPROVAL FOR THE IMPLEMENTATION OF A SKIP-LOT TESTING OPTION FOR THE FORCE TO CLOSE TEST.
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