Cardiovascular Devices; Reclassification of Intra-Aortic Balloon and Control Systems for Acute Coronary Syndrome, Cardiac and Non-Cardiac Surgery, or Complications of Heart Failure; Effective Date of Requirement for Premarket Approval for Intra-Aortic Balloon and Control Systems for Septic Shock or Pulsatile Flow Generation
fda-device · Food and Drug Administration · Rule · Published 2013-12-30 · Effective 2013-12-30 · 78 FR 79300
Document
Document number
2013-31218
Federal Register citation
78 FR 79300
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-0581
Abstract
The Food and Drug Administration (FDA) is issuing a final order to reclassify intra-aortic balloon and control system (IABP) devices when indicated for acute coronary syndrome, cardiac and non- cardiac surgery, or complications of heart failure, 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 IABPs when indicated for septic shock or pulsatile flow generation.