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

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

Unknown
FDA source (opens on fda.gov)

NKE is the FDA product code for Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P), a class III device type. FDA's definition for this code reads: "These devices are indicated for patients who have moderate to severe heart failure. These new devices use an additional lead to provide synchronized pacing of the heart, in addition to the regular features of a pacemaker. These products are sought for the treatment of patients who have moderate to severe heart failure". As of , FDA records hold no 510(k) clearances under this code and 28 recalls.

Classification record

Product code
NKE
Device name
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
FDA definition
These devices are indicated for patients who have moderate to severe heart failure. These new devices use an additional lead to provide synchronized pacing of the heart, in addition to the regular features of a pacemaker. These products are sought for the treatment of patients who have moderate to severe heart failure.
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
28

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 18 companies shown, in name order