Cardiva VASCADE Family

FDA Premarket Approval P120016 S030

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

DeviceCardiva VASCADE Family
Generic NameDevice, Hemostasis, Vascular
ApplicantCARDIVA MEDICAL, INC.2900 Lakeside Drivesuite 160santa Clara, CA 95054 PMA NumberP120016 Supplement NumberS030 Date Received10/11/2022 Decision Date11/08/2022 Product Code MGB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-10-11
Decision Date2022-11-08
PMAP120016
SupplementS030
Product CodeMGB 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressCARDIVA MEDICAL, INC.
2900 Lakeside Drive
suite 160
santa Clara, CA 95054 PMA NumberP120016 Supplement NumberS030 Date Received10/11/2022 Decision Date11/08/2022 Product Code MGB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
an Alternative To Batch Testing For Bacterial Endotoxins

Supplemental Filings

Supplement NumberDateSupplement Type
P120016Original Filing
S030 2022-10-11 30-day Notice
S029
S028 2021-02-08 Normal 180 Day Track
S027 2019-07-08 Normal 180 Day Track
S026 2018-11-23 Normal 180 Day Track No User Fee
S025 2018-07-10 Real-time Process
S024 2018-05-30 Panel Track
S023 2017-03-20 30-day Notice
S022 2017-01-17 30-day Notice
S021 2016-11-04 Normal 180 Day Track
S020 2016-06-03 Real-time Process
S019 2016-01-07 30-day Notice
S018 2015-11-16 30-day Notice
S017 2015-11-03 135 Review Track For 30-day Notice
S016 2015-06-29 Special (immediate Track)
S015 2015-05-18 Real-time Process
S014 2015-04-03 Normal 180 Day Track No User Fee
S013 2015-03-12 30-day Notice
S012 2015-03-03 30-day Notice
S011 2015-02-25 30-day Notice
S010 2015-02-18 30-day Notice
S009 2015-02-09 30-day Notice
S008 2014-12-12 30-day Notice
S007 2014-10-20 30-day Notice
S006 2014-09-29 30-day Notice
S005 2014-08-18 135 Review Track For 30-day Notice
S004 2014-08-18 Real-time Process
S003 2014-06-27 30-day Notice
S002 2014-03-31 Real-time Process
S001 2014-03-18 30-day Notice

NIH GUDID Devices

Device IDPMASupp
M729700580I1 P120016 000
M729700500DX1 P120016 000
M729800612C2 P120016 024

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.