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Device | Obalon Touch Inflation System |
Generic Name | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
Applicant | ReShape Lifesciences, Inc. 1001 Calle Amanecer San Clemente, CA 92673 |
PMA Number | P160001 |
Supplement Number | S007 |
Date Received | 11/01/2017 |
Decision Date | 09/25/2018 |
Product Code |
LTI |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement Approval for the Obalon Touch Inflation System (as an alternative to the EzFill Inflation System) to be used with the Obalon Balloon System. |