PMA P140012S001
- Device
- RESHAPE INTEGRATED DUAL BALLOON SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P140012
- Supplement
- S001
- Product code
- LTI
- Decision date
- 2016-01-14
- Classification
- Implant, Intragastric For Morbid Obesity
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
Current openFDA PMA Record#
- Device
- RESHAPE INTEGRATED DUAL BALLOON SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P140012
- Supplement
- S001
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2016-01-14
- Decision code
- APPR
- Date received
- 2015-08-26
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.