OBALON BALLOON SYSTEM
FDA premarket approval P160001/S038 · decided 2019-05-29
Approval details
- PMA number
- P160001
- Supplement
- S038
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- OBALON BALLOON SYSTEM
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Medtimo, Inc.
- Date received
- 2019-04-19
- Decision date
- 2019-05-29
- Days to decision
- 40 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Eden Prairie, MN
- Statement
- This PMA includes the evaluation of the Obalon Navigation Touch System (NTS) implant procedure and device. P160001 was approved on 9/08/2016 , and P160001/S020 was approved on 12/20/2018 with the following conditions of approval: In addition to the Annual Report requirements, you must provide the following data in post-approval study (PAS) reports for each PAS listed below. Separate PAS Progress Reports must be submitted for each study every six (6) months during the first two (2) years of the s
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