ReShape Lap-Band System
FDA premarket approval P000008/S051 · decided 2025-07-11
Approval details
- PMA number
- P000008
- Supplement
- S051
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ReShape Lap-Band System
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Medtimo, Inc.
- Date received
- 2025-06-11
- Decision date
- 2025-07-11
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Eden Prairie, MN
- Statement
- addition of a contract supplier, known as Needle Tech Products, for the Lap-Band System Access Port Needles
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