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2013-12-28
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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
Rules and Regulations
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D09002ee1bdc86499
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
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.
78 FR 79304
https://www.govinfo.gov/app/details/FR-2013-12-30/2013-31216
2013-31216
fr30de13-11
4160-01-P
Docket No. FDA-2013-N-0487
https://www.govinfo.gov/app/details/FR-2013-12-30/2013-31216
https://www.govinfo.gov/content/pkg/FR-2013-12-30/html/2013-31216.htm
https://www.govinfo.gov/content/pkg/FR-2013-12-30/pdf/2013-31216.pdf
Medical Devices
5 p.
79304
79308
78 FR 79304
Code of Federal Regulations
Title 21 Part 870
21 CFR Part 870
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; Federal Register Vol. 78, Issue
RULE
2013-31216
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2013-12-30
Docket No. FDA-2013-N-0487
4160-01-P
2013-31216
Final order.
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.
This order is effective December 30, 2013.
Angela Krueger, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1666, Silver Spring, MD 20993, 301-796-6380, angela.krueger@fda.hhs.gov.
Medical Devices
Cardiovascular Devices:
Reclassification of External Counter-Pulsating Devices for Treatment of Chronic Stable Angina, etc.
,
angela.krueger@fda.hhs.gov
Federal Register
Vol. 78, no. 250
Office of the Federal Register, National Archives and Records Administration
2013-12-30
continuing
daily
deposited
born digital
294 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2013-12-30
P0b002ee186bede7f
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr30de13
https://www.govinfo.gov/app/details/FR-2013-12-30
https://www.govinfo.gov/content/pkg/FR-2013-12-30/pdf/FR-2013-12-30.pdf
https://www.govinfo.gov/content/pkg/FR-2013-12-30/xml/FR-2013-12-30.xml
fdlp
79283
79565
DGPO
2013-12-28
2023-04-29
FR-2013-12-30
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eng
FR
FR-2013-12-30
78
250