PMA P200039S003
- Device
- Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 IVL Catheter
- Applicant
- Shockwave Medical, Inc.
- PMA number
- P200039
- Supplement
- S003
- Product code
- QMG
- Decision date
- 2021-07-22
- Generic name
- Shockwave intravascular lithotripsy system
- Approval order statement
- New class 8 cleanroom.
Current openFDA PMA Record#
- Device
- Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 IVL Catheter
- Applicant
- Shockwave Medical, Inc.
- PMA number
- P200039
- Supplement
- S003
- Product code
- QMG
- Generic name
- Shockwave intravascular lithotripsy system
- Decision date
- 2021-07-22
- Decision code
- OK30
- Date received
- 2021-07-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New class 8 cleanroom.