Shockwave Intravascular Lithotripsy System
The Shockwave Intravascular Lithotripsy System is a cardiovascular interventional device indicated for the dilatation of coronary arteries prior to stenting, using shockwave energy to modify calcified plaque and improve vessel compliance. This device is classified as FDA Class 3, the highest risk category, which requires Premarket Approval (PMA) demonstrating safety and effectiveness through clinical evidence. Product code QMG, reviewed by the Cardiovascular panel; no regulation number is assigned. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QMG
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- CV
- Submission Type
- 2
Device Characteristics
Definition
Dilatation of coronary arteries prior to stenting
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.