LAP-BAND Adjustable Gastric Banding System
FDA premarket approval P000008/S042 · decided 2018-01-23
Approval details
- PMA number
- P000008
- Supplement
- S042
- 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
- 2018-01-16
- Decision date
- 2018-01-23
- Days to decision
- 7 days
- Decision code
- OK30
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Eden Prairie, MN
- Statement
- Change of a suppliers manufacturing site location for production of the thermoform trays used in primary packaging of the Lap-Band system.
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