|
Device | Impella 2.5 System, Impella CP System, Impella CP with SmartAssist System, Impella 5.0 System, Impella LD System,Impella |
Generic Name | Temporary non-roller type left heart support blood pump |
Applicant | ABIOMED, INC. 22 CHERRY HILL DR. DANVERS, MA 01923 |
PMA Number | P140003 |
Supplement Number | S088 |
Date Received | 08/05/2021 |
Decision Date | 04/19/2022 |
Product Code |
OZD |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for revising the Instructions for Use to allow the use of sodium bicarbonate (25 or 50 mEq/L) as an alternative to heparin (25 or 50 U/mL) in the purge fluid during clinical use of the Impella catheters in patients intolerant to heparin or in whom heparin is contraindicated. |
Post-Approval Study | Show Report Schedule and Study Progress |