PMA P160001S001
- Device
- OBALON BALLOON SYSTEM
- Applicant
- Medtimo, Inc.
- PMA number
- P160001
- Supplement
- S001
- Product code
- LTI
- Decision date
- 2017-07-19
- Classification
- Implant, Intragastric For Morbid Obesity
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- Approval of the protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- OBALON BALLOON SYSTEM
- Applicant
- Medtimo, Inc.
- PMA number
- P160001
- Supplement
- S001
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2017-07-19
- Decision code
- APPR
- Date received
- 2016-10-14
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval of the protocol for the post-approval study (PAS) protocol.