LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
FDA premarket approval P000008/S037 · decided 2016-03-28
Approval details
- PMA number
- P000008
- Supplement
- S037
- 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
- 2016-01-29
- Decision date
- 2016-03-28
- Days to decision
- 59 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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