|
Device | Impella RP |
Generic Name | Temporary non-roller type right heart support blood pump |
Regulation Number | 870.4360 |
Applicant | Abiomed, Inc. 22 Cherry Hill Drive Danvers, MA 01923 |
PMA Number | P170011 |
Supplement Number | S007 |
Date Received | 07/31/2018 |
Decision Date | 08/22/2018 |
Product Code |
PYX |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Addition of an alternative biological indicator (BI) for the sterilization of all Impella family of catheters and the adoption of Impella CP with SmartAssist into the existing sterilization cycle for other Impella catheters at an alternate site. |