ReShape Lap-Band System
FDA premarket approval P000008/S049 · decided 2024-01-26
Approval details
- PMA number
- P000008
- Supplement
- S049
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ReShape Lap-Band System
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Medtimo, Inc.
- Date received
- 2024-01-23
- Decision date
- 2024-01-26
- Days to decision
- 3 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Eden Prairie, MN
- Statement
- approval to change the product trade name from Lap-Band Adjustable Gastric Banding System to ReShape Lap-Band Adjustable Gastric Banding System
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