PMA P070009S006
- Device
- REALIZE ADJUSTABLE GASTRIC BAND-C
- Applicant
- Obtech Medical GmbH
- PMA number
- P070009
- Supplement
- S006
- Product code
- LTI
- Decision date
- 2009-10-06
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- ADDITION OF AN IN-HOUSE MANUFACTURING SITE FOR A DEVICE COMPONENT AS WELL AS CHANGES TO SEVERAL MANUFACTURING STEPS.
Current openFDA PMA Record#
- Device
- REALIZE ADJUSTABLE GASTRIC BAND-C
- Applicant
- Obtech Medical GmbH
- PMA number
- P070009
- Supplement
- S006
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2009-10-06
- Decision code
- OK30
- Date received
- 2009-09-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF AN IN-HOUSE MANUFACTURING SITE FOR A DEVICE COMPONENT AS WELL AS CHANGES TO SEVERAL MANUFACTURING STEPS.