PMA P200039S017

Device: Shockwave Intravascular Lithotripsy (IVL) 825 Series Generators
Applicant: Shockwave Medical, Inc.
PMA number: P200039
Supplement: S017
Product code: QMG
Decision date: 2025-06-27
Classification: Cardiovascular
Generic name: Shockwave intravascular lithotripsy system
Approval order statement: approval for three changes in the generator portion of the device: an alternate relay, alternate 14.4V battery, and revisions to Shockwave IVL 825 series generator Operator Manual associated with the alternate battery change

Current openFDA PMA Record#

Device: Shockwave Intravascular Lithotripsy (IVL) 825 Series Generators
Applicant: Shockwave Medical, Inc.
PMA number: P200039
Supplement: S017
Product code: QMG
Generic name: Shockwave intravascular lithotripsy system
Decision date: 2025-06-27
Decision code: APPR
Date received: 2025-05-08
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for three changes in the generator portion of the device: an alternate relay, alternate 14.4V battery, and revisions to Shockwave IVL 825 series generator Operator Manual associated with the alternate battery change