LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM
FDA premarket approval P000008/S028 · decided 2014-10-07
Approval details
- PMA number
- P000008
- Supplement
- S028
- Supplement type
- Normal 180 Day 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
- 2012-06-01
- Decision date
- 2014-10-07
- Days to decision
- 858 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Eden Prairie, MN
- Statement
- APPROVAL FOR DESIGN CHANGES TO THE RAPIDPORT EZ ACCESS PORT, DESIGN CHANGES TO THE RAPIDPORT EZ ACCESS PORT APPLIER, AND PACKAGING CHANGES.
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