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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 21 Results
productcode LTI PMA Number p Decision Date From 1/1/2019 Decision Date To 1/1/2020
 
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PMA
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LAP-BAND System ReShape Lifesciences, Inc. P000008 S047 11/13/2019
Obalon Balloon System ReShape Lifesciences, Inc. P160001 S033 10/18/2019
Obalon Touch Dispenser ReShape Lifesciences, Inc. P160001 S039 08/20/2019
Obalon Balloon System ReShape Lifesciences, Inc. P160001 S042 08/08/2019
Obalon Touch Dispenser ReShape Lifesciences, Inc. P160001 S043 07/25/2019
ORBERA Intragastric Balloon System Boston Scientific Corporation P140008 S018 07/19/2019
Obalon Balloon System with Navigation and Touch ReShape Lifesciences, Inc. P160001 S031 07/05/2019
Obalon Touch Dispenser ReShape Lifesciences, Inc. P160001 S040 07/03/2019
Obalon Balloon Kit, Obalon Navigation Balloon Kit,... ReShape Lifesciences, Inc. P160001 S041 07/03/2019
ORBERA Intragastric Balloon System Boston Scientific Corporation P140008 S017 06/03/2019
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