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

Implantable Pulse Generator, Pacemaker (Non-Crt)

Unknown
FDA source (opens on fda.gov)

LWP is the FDA product code for Implantable Pulse Generator, Pacemaker (Non-Crt), a class III device type. FDA's definition for this code reads: "These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary". As of , FDA records hold no 510(k) clearances under this code and 113 recalls.

Classification record

Product code
LWP
Device name
Implantable Pulse Generator, Pacemaker (Non-Crt)
FDA definition
These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing 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
113

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 27 companies shown, in name order