# Cardiovascular Devices; Reclassification of External Counter-Pulsating Devices for Treatment of Chronic Stable Angina; Effective Date of Requirement for Premarket Approval for External Counter-Pulsating Devices for Other Specified Intended Uses
> **Food and Drug Administration** · Final order. · Published 2013-12-30 · Effective 2013-12-30 · 78 FR 79304
## Document
- **Document number:** 2013-31216
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 78 FR 79304
- **CFR reference:** 21 CFR 870
- **Publication date:** 2013-12-30
- **Effective date:** 2013-12-30
- **HHS docket:** Docket No. FDA-2013-N-0487
## Abstract

The Food and Drug Administration (FDA) is issuing a final order to reclassify external counter-pulsating (ECP) devices for treatment of chronic stable angina that is refractory to optimal anti- anginal medical therapy and without options for revascularization, which is a preamendments class III device, into class II (special controls), and to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for ECP devices for other intended uses specified in this proposed order.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2013/12/30/2013-31216/cardiovascular-devices-reclassification-of-external-counter-pulsating-devices-for-treatment-of)
---
*AI Analytics · CC0 1.0*