Impella RP System

FDA premarket approval P170011 · Temporary non-roller type right heart support blood pump

PMA numberP170011

Approval

Applicant
Abiomed, Inc.
Received
March 30, 2017
Decision date
September 20, 2017 (APPR)
Supplements
61, latest April 1, 2026
Product code
PYX – Temporary Non-Roller Type Right Heart Support Blood Pump

Official FDA PMA record

Approval order statement

Approval for the Impella RP® System. This device is indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area greater than or equal to 1.5 m2, who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.