Impella RP System

Temporary Non-roller Type Right Heart Support Blood Pump

FDA Premarket Approval P170011 S019

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

To use an additional sterilization chamber at the current sterilization facility for the ethelene oxide sterilization of impella products

DeviceImpella RP System
Classification NameTemporary Non-roller Type Right Heart Support Blood Pump
Generic NameTemporary Non-roller Type Right Heart Support Blood Pump
ApplicantAbiomed, Inc.
Date Received2019-10-30
Decision Date2019-11-25
PMAP170011
SupplementS019
Product CodePYX
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Abiomed, Inc. 22 Cherry Hill Drive danvers, MA 01923

Supplemental Filings

Supplement NumberDateSupplement Type
P170011Original Filing
S019 2019-10-30 30-day Notice
S018 2019-10-25 30-day Notice
S017 2019-09-30 30-day Notice
S016 2019-09-03 30-day Notice
S015
S014 2019-08-26 Special (immediate Track)
S013 2019-05-31 30-day Notice
S012 2019-05-31 30-day Notice
S011 2019-03-15 Normal 180 Day Track No User Fee
S010 2019-03-15 Special (immediate Track)
S009
S008 2018-09-06 Real-time Process
S007 2018-07-31 30-day Notice
S006 2018-07-25 30-day Notice
S005 2018-02-27 Real-time Process
S004 2018-01-09 30-day Notice
S003 2017-12-18 Normal 180 Day Track No User Fee
S002 2017-12-18 Normal 180 Day Track No User Fee
S001 2017-12-05 Real-time Process

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