Shockwave Intravascular Lithotripsy (IVL) Generator, Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2

FDA Premarket Approval P200039 S007

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.

Pre-market Approval Supplement Details

DeviceShockwave Intravascular Lithotripsy (IVL) Generator, Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2
Generic NameShockwave Intravascular Lithotripsy System
ApplicantShockwave Medical, Inc.5403 Betsy Ross Drivesanta Clara, CA 95054 PMA NumberP200039 Supplement NumberS007 Date Received06/03/2022 Decision Date09/01/2022 Product Code QMG  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
Date Received2022-06-03
Decision Date2022-09-01
PMAP200039
SupplementS007
Product CodeQMG 
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination ProductNo
Applicant AddressShockwave Medical, Inc.
5403 Betsy Ross Drive
santa Clara, CA 95054 PMA NumberP200039 Supplement NumberS007 Date Received06/03/2022 Decision Date09/01/2022 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 A Modification To Your Generator Enclosure

Supplemental Filings

Supplement NumberDateSupplement Type
P200039Original Filing
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

Device IDPMASupp
00195451000119 P200039 000
00195451000102 P200039 000
00195451000096 P200039 000
00195451000089 P200039 000

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