CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM
Device Facts
| Record ID | DEN050006 |
|---|---|
| Device Name | CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM |
| Applicant | Cardiomems, Inc. |
| Product Code | NQH · Cardiovascular |
| Decision Date | Oct 28, 2005 |
| Decision | DENG |
| Submission Type | Post-NSE |
| Regulation | 21 CFR 870.2855 |
| Device Class | Class 2 |
Regulatory Classification
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.
