PMA P070009S014
- Device
- REALIZE ADJUSTABLE GASTRIC BANDS WITH INJECTION PORT & APPLIER
- Applicant
- Obtech Medical GmbH
- PMA number
- P070009
- Supplement
- S014
- Product code
- LTI
- Decision date
- 2011-12-02
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- CHANGE IN THE PACKAGING PROCESS.
Current openFDA PMA Record#
- Device
- REALIZE ADJUSTABLE GASTRIC BANDS WITH INJECTION PORT & APPLIER
- Applicant
- Obtech Medical GmbH
- PMA number
- P070009
- Supplement
- S014
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2011-12-02
- Decision code
- OK30
- Date received
- 2011-11-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE PACKAGING PROCESS.