This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2+ Coronary Intravascular Lithotripsy (IVL) Catheter |
| Generic Name | Shockwave Intravascular Lithotripsy System |
| Applicant | Shockwave Medical, Inc.5403 Betsy Ross Drivesanta Clara, CA 95054 PMA NumberP200039 Supplement NumberS008 Date Received10/11/2022 Decision Date12/13/2022 Product Code QMG Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No |
| Date Received | 2022-10-11 |
| Decision Date | 2022-12-13 |
| PMA | P200039 |
| Supplement | S008 |
| Product Code | QMG |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Shockwave Medical, Inc. 5403 Betsy Ross Drive santa Clara, CA 95054 PMA NumberP200039 Supplement NumberS008 Date Received10/11/2022 Decision Date12/13/2022 Product Code QMG Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement approval For The Addition Of A Sterile Sleeve And Labeling Modifications, Including An Increase In The Maximum Pulse Count From 80 To 120. |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00195451000119 | P200039 | 000 |
| 00195451000102 | P200039 | 000 |
| 00195451000096 | P200039 | 000 |
| 00195451000089 | P200039 | 000 |
| 00195451000034 | P200039 | 008 |
| 00195451000027 | P200039 | 008 |
| 00195451000010 | P200039 | 008 |
| 00195451000003 | P200039 | 008 |