510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OSRClass III

Pacemaker/Icd/Crt Non-Implanted Components

Unknown
FDA source (opens on fda.gov)

OSR is the FDA product code for Pacemaker/Icd/Crt Non-Implanted Components, a class III device type. FDA's definition for this code reads: "Pacemaker/ICD/CRT non-implanted components provide programming, interrogation, printing, remote monitoring, and communication between the pulse generator and the health care provider". As of , FDA records hold no 510(k) clearances under this code and 15 recalls.

Classification record

Product code
OSR
Device name
Pacemaker/Icd/Crt Non-Implanted Components
FDA definition
Pacemaker/ICD/CRT non-implanted components provide programming, interrogation, printing, remote monitoring, and communication between the pulse generator and the health care provider.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
15

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 28 companies shown, in name order