Lap-Band Adjustable Gastric Banding System
FDA premarket approval P000008/S048 · decided 2023-12-12
Approval details
- PMA number
- P000008
- Supplement
- S048
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Lap-Band Adjustable Gastric Banding System
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Medtimo, Inc.
- Date received
- 2023-05-25
- Decision date
- 2023-12-12
- Days to decision
- 201 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Eden Prairie, MN
- Statement
- a product line extension, referred to as ReShape Lap-Band® 2.0 FLEX System, which contains the FLEX Tubing. The FLEX Tubing acts as a reservoir within the ReShape Lap-Band® 2.0 FLEX System and can expand to hold extra saline out of the band cuff, allowing the band stoma to temporarily dilate and facilitate the passage of a food bolus through the band
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