PMA P070009S007
- Device
- REALIZE ADJUSTABLE GASTRIC BAND-C AND INJECTION PORT
- Applicant
- Obtech Medical GmbH
- PMA number
- P070009
- Supplement
- S007
- Product code
- LTI
- Decision date
- 2010-08-10
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- APPROVAL FOR CONVERTING A MANUAL TO AN AUTOMATED PIN ORIENTING AND FEEDING ASSEMBLY PROCESS.
Current openFDA PMA Record#
- Device
- REALIZE ADJUSTABLE GASTRIC BAND-C AND INJECTION PORT
- Applicant
- Obtech Medical GmbH
- PMA number
- P070009
- Supplement
- S007
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2010-08-10
- Decision code
- APPR
- Date received
- 2009-12-22
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR CONVERTING A MANUAL TO AN AUTOMATED PIN ORIENTING AND FEEDING ASSEMBLY PROCESS.