REALIZE ADJUSTABLE GASTRIC BAND/REALIZE INJECTION PORT
FDA premarket approval P070009/S002 · decided 2008-04-09
Approval details
- PMA number
- P070009
- Supplement
- S002
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- REALIZE ADJUSTABLE GASTRIC BAND/REALIZE INJECTION PORT
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Obtech Medical GmbH
- Date received
- 2008-03-13
- Decision date
- 2008-04-09
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Zug
- Statement
- CHANGES TO THE MANUFACTURING METHOD AND ASSEMBLY FOR THE REALIZE ADJUSTABLE GASTRIC BAND ANDREALIZE INJECTION PORT.
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