REALIZE ADJUSTABLE GASTRIC BAND-C
FDA premarket approval P070009/S006 · decided 2009-10-06
Approval details
- PMA number
- P070009
- Supplement
- S006
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- REALIZE ADJUSTABLE GASTRIC BAND-C
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Obtech Medical GmbH
- Date received
- 2009-09-08
- Decision date
- 2009-10-06
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Zug
- Statement
- ADDITION OF AN IN-HOUSE MANUFACTURING SITE FOR A DEVICE COMPONENT AS WELL AS CHANGES TO SEVERAL MANUFACTURING STEPS.
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