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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device syringe, balloon inflation, exempt
Definition This product code is the class II exempt counterpart of MAV, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 870.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.
Product CodePTM
Regulation Number 870.1650
Device Class 2

MDR Year MDR Reports MDR Events
2020 1 1
2021 1 1
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Material Rupture 1 1
Contamination /Decontamination Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4
Cardiac Arrest 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Merit Medical Systems, Inc. II Jul-29-2021
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