PMA P070009S002
- Device
- REALIZE ADJUSTABLE GASTRIC BAND/REALIZE INJECTION PORT
- Applicant
- Obtech Medical GmbH
- PMA number
- P070009
- Supplement
- S002
- Product code
- LTI
- Decision date
- 2008-04-09
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- CHANGES TO THE MANUFACTURING METHOD AND ASSEMBLY FOR THE REALIZE ADJUSTABLE GASTRIC BAND ANDREALIZE INJECTION PORT.
Current openFDA PMA Record#
- Device
- REALIZE ADJUSTABLE GASTRIC BAND/REALIZE INJECTION PORT
- Applicant
- Obtech Medical GmbH
- PMA number
- P070009
- Supplement
- S002
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2008-04-09
- Decision code
- OK30
- Date received
- 2008-03-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO THE MANUFACTURING METHOD AND ASSEMBLY FOR THE REALIZE ADJUSTABLE GASTRIC BAND ANDREALIZE INJECTION PORT.