PMA P140012S010
- Device
- ReShape Integrated Dual Ballon System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140012
- Supplement
- S010
- Product code
- LTI
- Decision date
- 2017-06-27
- Classification
- Implant, Intragastric For Morbid Obesity
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- ReShape Integrated Dual Ballon System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140012
- Supplement
- S010
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2017-06-27
- Decision code
- APPR
- Date received
- 2017-04-28
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.