REALIZE ADJUSTABLE GASTRIC BAND-C AND INJECTION PORT
FDA premarket approval P070009/S007 · decided 2010-08-10
Approval details
- PMA number
- P070009
- Supplement
- S007
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- REALIZE ADJUSTABLE GASTRIC BAND-C AND INJECTION PORT
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Obtech Medical GmbH
- Date received
- 2009-12-22
- Decision date
- 2010-08-10
- Days to decision
- 231 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Zug
- Statement
- APPROVAL FOR CONVERTING A MANUAL TO AN AUTOMATED PIN ORIENTING AND FEEDING ASSEMBLY PROCESS.
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