PMA P200039S007
- Device
- Shockwave Intravascular Lithotripsy (IVL) Generator, Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2
- Applicant
- Shockwave Medical, Inc.
- PMA number
- P200039
- Supplement
- S007
- Product code
- QMG
- Decision date
- 2022-09-01
- Generic name
- Shockwave intravascular lithotripsy system
- Approval order statement
- Approval for a modification to your generator enclosure.
Current openFDA PMA Record#
- Device
- Shockwave Intravascular Lithotripsy (IVL) Generator, Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2
- Applicant
- Shockwave Medical, Inc.
- PMA number
- P200039
- Supplement
- S007
- Product code
- QMG
- Generic name
- Shockwave intravascular lithotripsy system
- Decision date
- 2022-09-01
- Decision code
- APPR
- Date received
- 2022-06-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a modification to your generator enclosure.