LAP-BAND ADJUSTABLE GASTIC BANDING SYSTEM
FDA premarket approval P000008/S035 · decided 2016-05-23
Approval details
- PMA number
- P000008
- Supplement
- S035
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LAP-BAND ADJUSTABLE GASTIC BANDING SYSTEM
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Medtimo, Inc.
- Date received
- 2015-10-26
- Decision date
- 2016-05-23
- Days to decision
- 210 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Eden Prairie, MN
- Statement
- approval for a manufacturing site located at Apollo Endosurgery, Building 13.3, Zona Franca Coyol, Alajuela, Costa Rica
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