FDA PRODUCT CODE · CLASS III
LWS — Implantable Cardioverter Defibrillator (Non-Crt)
These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.
What these counts are not
Clearance and recall counts are SPEQ’s aggregation of FDA’s own published records for the code. A recall count is a measure of history, not of a device’s safety, neither number is an FDA rating, and SPEQ is not affiliated with the FDA.
What this classification requires
Every statement below is FDA’s own classification record for this product code, quoted from the device classification field reference. The SPEQ reading beneath each one is SPEQ’s interpretation of what it means for the work, and is not FDA text.
PMA
SPEQ READINGPremarket approval under 21 CFR Part 814. FDA reviews safety and effectiveness directly rather than by comparison, so clinical evidence is normally expected and the quality system is inspected before approval rather than after marketing.
Class III (high risk): general controls and Premarket Approval (PMA)
SPEQ READINGGeneral controls are insufficient to assure safety and effectiveness, so approval rests on direct evidence rather than equivalence.
Device is not eligible for The Voluntary Malfunction Summary Reporting Program
SPEQ READINGIndividual malfunction reporting under 21 CFR Part 803 applies. The complaint-handling system has to produce a decision per event, not per period.
Not exempt due to Good Manufacturing Practice (GMP)/Quality System
SPEQ READINGThe full Quality Management System Regulation (21 CFR 820, incorporating ISO 13485:2016) applies, and is what an FDA inspection of this device will be conducted against.
Device is implantable
SPEQ READINGImplant status raises the evidentiary bar on biocompatibility and on traceability from finished device back to material lot.
Device is used for life sustaining purposes.
SPEQ READINGA life-sustaining designation is what brings device tracking under 21 CFR Part 821 into scope, and it raises what a risk file has to say about single-fault conditions.
Device is not a candidate for a third party review program
SPEQ READINGFDA reviews any premarket notification for this code directly.
Recent clearances
Recent recalls
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) a
During internal review of Polaris battery assembly data from the HiPot operation, a test systems engineer noticed that some batteries had gone through the High Potential test twice. This was able to occur because the test screen did not prevent retesting after a failure. Some batteries were therefor
The software application on the Programmer/Recorder/Monitor (PRM) for Implantable Pulse Generators will display certain diagnostic dates incorrectly, with a year in the 1990s.
Electrical overstress may lead to device malfunction.
Electrical overstress may lead to device malfunction.
There is potential for fractures which results in the inability to delivery therapy.
Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).
Source: FDA device classification, 510(k)/PMA, and recall datasets. Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. Browse every product code SPEQ tracks →