# 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
> **Food and Drug Administration** · Final order. · Published 2013-12-30 · Effective 2013-12-30 · 78 FR 79300
## Document
- **Document number:** 2013-31218
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 78 FR 79300
- **CFR reference:** 21 CFR 870
- **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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2013/12/30/2013-31218/cardiovascular-devices-reclassification-of-intra-aortic-balloon-and-control-systems-for-acute)
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