Obalon Balloon Kit
FDA premarket approval P160001/S019 · decided 2018-07-11
Approval details
- PMA number
- P160001
- Supplement
- S019
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Obalon Balloon Kit
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Medtimo, Inc.
- Date received
- 2018-06-12
- Decision date
- 2018-07-11
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Eden Prairie, MN
- Statement
- Modify four related manufacturing fixtures, and introduce a new fixture and associated process steps for the balloon film trimming process.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.