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

Implantable Cardioverter Defibrillator (Non-Crt)

Unknown
FDA source (opens on fda.gov)

LWS is the FDA product code for Implantable Cardioverter Defibrillator (Non-Crt), a class III device type. FDA's definition for this code reads: "These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary". As of , FDA records hold no 510(k) clearances under this code and 219 recalls.

Classification record

Product code
LWS
Device name
Implantable Cardioverter Defibrillator (Non-Crt)
FDA definition
These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.
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
219

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 38 companies shown, in name order