← Product Code [NQH](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/NQH) · DEN050006

# CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM (DEN050006)

_Cardiomems, Inc. · NQH · Oct 28, 2005 · Cardiovascular · DENG_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/NQH/DEN050006

## Device Facts

- **Applicant:** Cardiomems, Inc.
- **Product Code:** [NQH](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/NQH.md)
- **Decision Date:** Oct 28, 2005
- **Decision:** DENG
- **Submission Type:** Post-NSE
- **Regulation:** 21 CFR 870.2855
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

Implantable intra-aneurysm pressure measurement system is a device used to measure the intra-sac pressure in a vascular aneurysm. The device consists of a pressure transducer that is implanted into the aneurysm and a monitor that reads the pressure from the transducer.

## Special Controls

*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Implantable Intra-Aneurysm Pressure Measurement System.” See § 870.1 (e) for the availability of this guidance document.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/NQH/DEN050006](https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/NQH/DEN050006)

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