PMA P200039S012

Device: Shockwave C2/C2+ Intravascular Lithotripsy (IVL) Catheter, IVL Generator and Connector Cable Kit, IVL Connector Cable (r
Applicant: Shockwave Medical, Inc.
PMA number: P200039
Supplement: S012
Product code: QMG
Decision date: 2023-06-15
Classification: Cardiovascular
Generic name: Shockwave intravascular lithotripsy system
Approval order statement: Approval for a minor formulation change to the inner member.

Current openFDA PMA Record#

Device: Shockwave C2/C2+ Intravascular Lithotripsy (IVL) Catheter, IVL Generator and Connector Cable Kit, IVL Connector Cable (r
Applicant: Shockwave Medical, Inc.
PMA number: P200039
Supplement: S012
Product code: QMG
Generic name: Shockwave intravascular lithotripsy system
Decision date: 2023-06-15
Decision code: APPR
Date received: 2023-04-14
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a minor formulation change to the inner member.