Lap-Band Adjustable Gastric Banding System
FDA premarket approval P000008/S039 · decided 2017-10-02
Approval details
- PMA number
- P000008
- Supplement
- S039
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Lap-Band Adjustable Gastric Banding System
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Medtimo, Inc.
- Date received
- 2017-07-05
- Decision date
- 2017-10-02
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Eden Prairie, MN
- Statement
- Approval for the addition of the long-term data from the HERO-002 post-approval study, the addition of the MR Conditional labeling claim, and the addition of warnings for adverse events associated with device erosion and device migration/twisting/slipping.
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