PMA P200039S008

Device: Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2+ Coronary Intravascular Lithotripsy (IVL) Catheter
Applicant: Shockwave Medical, Inc.
PMA number: P200039
Supplement: S008
Product code: QMG
Decision date: 2022-12-13
Generic name: Shockwave intravascular lithotripsy system
Approval order statement: Approval for the addition of a sterile sleeve and labeling modifications, including an increase in the maximum pulse count from 80 to 120.

Current openFDA PMA Record#

Device: Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2+ Coronary Intravascular Lithotripsy (IVL) Catheter
Applicant: Shockwave Medical, Inc.
PMA number: P200039
Supplement: S008
Product code: QMG
Generic name: Shockwave intravascular lithotripsy system
Decision date: 2022-12-13
Decision code: APPR
Date received: 2022-10-11
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the addition of a sterile sleeve and labeling modifications, including an increase in the maximum pulse count from 80 to 120.