PMA P200039S010

Device: Shockwave Intravascular Lithotripsy (IVL) System (Shockwave IVL System) with Shockwave C2 and C2+ IVL Catheters
Applicant: Shockwave Medical, Inc.
PMA number: P200039
Supplement: S010
Product code: QMG
Decision date: 2023-03-22
Classification: Cardiovascular
Generic name: Shockwave intravascular lithotripsy system
Approval order statement: Approval for the addition of an alternate Field Programmable Gate Array (FPGA) component and minor Control Logic Board (CLB) design modifications.

Current openFDA PMA Record#

Device: Shockwave Intravascular Lithotripsy (IVL) System (Shockwave IVL System) with Shockwave C2 and C2+ IVL Catheters
Applicant: Shockwave Medical, Inc.
PMA number: P200039
Supplement: S010
Product code: QMG
Generic name: Shockwave intravascular lithotripsy system
Decision date: 2023-03-22
Decision code: APPR
Date received: 2022-12-27
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the addition of an alternate Field Programmable Gate Array (FPGA) component and minor Control Logic Board (CLB) design modifications.