LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
FDA premarket approval P000008/S019 · decided 2011-09-16
Approval details
- PMA number
- P000008
- Supplement
- S019
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Medtimo, Inc.
- Date received
- 2010-07-02
- Decision date
- 2011-09-16
- Days to decision
- 441 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Eden Prairie, MN
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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