PMA P070009S009
- Device
- REALIZE ADJUSTABLE GASTRIC BAND WITH INJECTION PORT & APPLIER
- Applicant
- Obtech Medical GmbH
- PMA number
- P070009
- Supplement
- S009
- Product code
- LTI
- Decision date
- 2010-06-04
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- APPROVAL FOR MINOR CHANGES TO THE LABELING.
Current openFDA PMA Record#
- Device
- REALIZE ADJUSTABLE GASTRIC BAND WITH INJECTION PORT & APPLIER
- Applicant
- Obtech Medical GmbH
- PMA number
- P070009
- Supplement
- S009
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2010-06-04
- Decision code
- APPR
- Date received
- 2010-05-07
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR MINOR CHANGES TO THE LABELING.