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 | OBALON BALLOON SYSTEM |
Generic Name | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
Applicant | ReShape Lifesciences, Inc. 1001 Calle Amanecer San Clemente, CA 92673 |
PMA Number | P160001 |
Supplement Number | S002 |
Date Received | 11/16/2016 |
Decision Date | 12/15/2016 |
Product Code |
LTI |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Change manufacturing specifications to narrow the EzFill Dispenser set point to the nearest 10 feet in clinical site altitude across a range of +/-150 feet in dispenser altitude. |
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