# Cardiovascular Devices; Reclassification of Nonroller-Type Cardiopulmonary Bypass Blood Pumps for Cardiopulmonary and Circulatory Bypass; Effective Date of Requirement for Premarket Approval for Nonroller-Type Cardiopulmonary Bypass Blood Pumps for Temporary Ventricular Support
> **Food and Drug Administration** · Final order. · Published 2015-06-08 · Effective 2015-06-08 · 80 FR 32307
## Document
- **Document number:** 2015-13889
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 80 FR 32307
- **CFR reference:** 21 CFR 870
- **Publication date:** 2015-06-08
- **Effective date:** 2015-06-08
- **HHS docket:** Docket No. FDA-2013-N-1518
## Abstract

The Food and Drug Administration (FDA) is issuing a final order to reclassify nonroller-type cardiopulmonary bypass blood pump (NRP) devices for cardiopulmonary and circulatory bypass, a preamendments class III device, into class II (special controls), and to require the filing of a premarket approval application (PMA) for NRP devices for temporary ventricular support. FDA is also revising the title and identification of the regulation for NRP devices in this order.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2015/06/08/2015-13889/cardiovascular-devices-reclassification-of-nonroller-type-cardiopulmonary-bypass-blood-pumps-for)
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