Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | Lap-Band Adjustable Gastric Banding System |
Generic Name | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
Applicant | ReShape Lifesciences, Inc. 1001 Calle Amanecer San Clemente, CA 92672 |
PMA Number | P000008 |
Supplement Number | S039 |
Date Received | 07/05/2017 |
Decision Date | 10/02/2017 |
Product Code |
LTI |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the addition of the long-term data from the HERO-002 post-approval study, the addition of the MR Conditional labeling claim, and the addition of warnings for adverse events associated with device erosion and device migration/twisting/slipping. |
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