PMA P200039S014
- Device
- Shockwave C2/C2+ Intravascular Lithotripsy (IVL) Catheter
- Applicant
- Shockwave Medical, Inc.
- PMA number
- P200039
- Supplement
- S014
- Product code
- QMG
- Decision date
- 2024-03-26
- Classification
- Cardiovascular
- Generic name
- Shockwave intravascular lithotripsy system
- Approval order statement
- an alternate manufacturing process and location
Current openFDA PMA Record#
- Device
- Shockwave C2/C2+ Intravascular Lithotripsy (IVL) Catheter
- Applicant
- Shockwave Medical, Inc.
- PMA number
- P200039
- Supplement
- S014
- Product code
- QMG
- Generic name
- Shockwave intravascular lithotripsy system
- Decision date
- 2024-03-26
- Decision code
- OK30
- Date received
- 2024-02-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an alternate manufacturing process and location