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

Pulse Generator, Permanent, Implantable

Unknown
FDA source (opens on fda.gov)

NVZ is the FDA product code for Pulse Generator, Permanent, Implantable, a class III device type. FDA's definition for this code reads: "Intended as a permanent implant to deliver pacing pulses and other pacing therapies through pacing leads implanted in the heart". As of , FDA records hold no 510(k) clearances under this code and 40 recalls.

Classification record

Product code
NVZ
Device name
Pulse Generator, Permanent, Implantable
FDA definition
Intended as a permanent implant to deliver pacing pulses and other pacing therapies through pacing leads implanted in the heart.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
Yes
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
40

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 29 companies shown, in name order