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
fda-device · Food and Drug Administration · Rule · Published 2013-12-30 · Effective 2013-12-30 · 78 FR 79304
Document
Document number
2013-31216
Federal Register citation
78 FR 79304
CFR reference
21 CFR 870
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
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.