Device classification

System, Pacing, Temporary, Acute, Internal Atrial Defibrillation

Unknown

Class IIIProduct code MTE
Open FDA's page for this record
Third party flag
N
Life sustain support flag
Y
Gmp exempt flag
N
Summary malfunction reporting
Eligible
Product code
MTE
Review panel
CV
Device name
System, Pacing, Temporary, Acute, Internal Atrial Defibrillation
Medical specialty description
Unknown
Device class
3
Implant flag
N
Submission type ID
2
Harmonized identifiers (openFDA)
PMA number
P020052, P990069
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.