PMA P070009S001
- Device
- SWEDISH ADJUSTABLE GASTRIC BAND
- Applicant
- Obtech Medical GmbH
- PMA number
- P070009
- Supplement
- S001
- Product code
- LTI
- Decision date
- 2008-09-09
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY.
Current openFDA PMA Record#
- Device
- SWEDISH ADJUSTABLE GASTRIC BAND
- Applicant
- Obtech Medical GmbH
- PMA number
- P070009
- Supplement
- S001
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2008-09-09
- Decision code
- APPR
- Date received
- 2007-10-29
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY.