← Product Code [KRG](/productcode/KRG) · P830045S076

# INTEGRITY AFX DR MODEL 5346 DUAL CHAMBER PULSE (P830045S076)

_St. Jude Medical, Inc. · KRG · Jul 11, 2001 · Cardiovascular · APPR_

**Canonical URL:** https://fda.innolitics.com/device/P830045S076

## Device Facts

- **Applicant:** St. Jude Medical, Inc.
- **Product Code:** [KRG](/productcode/KRG.md)
- **Decision Date:** Jul 11, 2001
- **Decision:** APPR
- **Regulation:** 21 CFR 870.3700
- **Device Class:** Class 3
- **Review Panel:** Cardiovascular

## Regulatory Identification

A pacemaker programmer is a device used to noninvasively change one or more of the electrical operating characteristics of a pacemaker.

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**Source:** [https://fda.innolitics.com/device/P830045S076](https://fda.innolitics.com/device/P830045S076)

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