LAP-BAND Adjustable Gastric Banding System
FDA premarket approval P000008/S038 · decided 2017-03-23
Approval details
- PMA number
- P000008
- Supplement
- S038
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LAP-BAND Adjustable Gastric Banding System
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Medtimo, Inc.
- Date received
- 2017-02-15
- Decision date
- 2017-03-23
- Days to decision
- 36 days
- Decision code
- OK30
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Eden Prairie, MN
- Statement
- Removal of the Ultrasonic Thickness Gauge (UTG) inspection step of the shell thickness of the band of the LAP-BAND Adjustable Gastric Banding System from the incoming product inspection protocol.
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