SWEDISH ADJUSTABLE GASTRIC BAND
FDA premarket approval P070009/S001 · decided 2008-09-09
Approval details
- PMA number
- P070009
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- SWEDISH ADJUSTABLE GASTRIC BAND
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Obtech Medical GmbH
- Date received
- 2007-10-29
- Decision date
- 2008-09-09
- Days to decision
- 316 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Zug
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY.
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