CentriMag Circulatory Support System

FDA Premarket Approval P170038 S001

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

Approval for a manufacturing site located at gerresheimer regensburg gmbh in pfreimd, germany for assembling and packaging the blood pump.

DeviceCentriMag Circulatory Support System
Generic NameVentricular (assist) Bypass
ApplicantAbbott
Date Received2020-01-08
Decision Date2020-03-20
PMAP170038
SupplementS001
Product CodeDSQ 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Abbott 6035 Stoneridge Drive pleasanton, CA 94588

Supplemental Filings

Supplement NumberDateSupplement Type
P170038Original Filing
S001 2020-01-08 Normal 180 Day Track No User Fee

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