CentriMag™ Circulatory Support System

FDA Premarket Approval P170038 S010

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

DeviceCentriMag™ Circulatory Support System
Generic NameVentricular (assist) Bypass
ApplicantAbbott6035 Stoneridge Drivepleasanton, CA 94588 PMA NumberP170038 Supplement NumberS010 Date Received04/13/2022 Decision Date05/11/2022 Product Code DSQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-04-13
Decision Date2022-05-11
PMAP170038
SupplementS010
Product CodeDSQ 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressAbbott
6035 Stoneridge Drive
pleasanton, CA 94588 PMA NumberP170038 Supplement NumberS010 Date Received04/13/2022 Decision Date05/11/2022 Product Code DSQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
to Add An Alternate Sub-tier Supplier For The PTFE Felt Material Used To Manufacture The Apical Sewing Ring For The CentriMag Cannula Drainage Kit

Supplemental Filings

Supplement NumberDateSupplement Type
P170038Original Filing
S010 2022-04-13 30-day Notice
S009 2022-03-15 30-day Notice
S008 2021-08-24 135 Review Track For 30-day Notice
S007 2021-08-02 Normal 180 Day Track No User Fee
S006 2021-07-08 30-day Notice
S005 2020-07-31 Normal 180 Day Track No User Fee
S004
S003 2020-04-01 30-day Notice
S002
S001 2020-01-08 Normal 180 Day Track No User Fee

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