Approval for the shockwave intravascular lithotripsy (ivl) system with shockwave c2 coronary intravascular lithotripsy (ivl) catheter. The shockwave intravascular lithotripsy (ivl) system with shockwave c2 ivl coronary catheter is indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting.
| Device | Shockwave Intravascular Litbotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter |
| Generic Name | Shockwave Intravascular Lithotripsy System |
| Applicant | Shockwave Medical, Inc. |
| Date Received | 2020-08-25 |
| Decision Date | 2021-02-12 |
| PMA | P200039 |
| Supplement | S |
| Product Code | QMG |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Shockwave Medical, Inc. 5403 Betsy Ross Drive santa Clara, CA 95054 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P200039 | | Original Filing |
| S009 |
2022-12-08 |
Normal 180 Day Track No User Fee |
| S008 |
2022-10-11 |
Real-time Process |
| S007 |
2022-06-03 |
Real-time Process |
| S006 |
2021-12-22 |
Real-time Process |
| S005 | | |
| S004 |
2021-10-22 |
Real-time Process |
| S003 |
2021-07-01 |
30-day Notice |
| S002 |
2021-03-11 |
Normal 180 Day Track No User Fee |
| S001 |
2021-03-10 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices