Philippines FDA registration CMDR-2025-05157

Stealth 360™ Peripheral Orbital Atherectomy System

Philippines·Cardiovascular Systems, Inc. - 1225 Old Highway 8 NW, St. Paul, MN 55112 USA·USA·Issued July 14, 2025 – July 14, 2030

Device information

Product Name: Stealth 360™ Peripheral Orbital Atherectomy System
Registration Number: CMDR-2025-05157

Manufacturer details

Manufacturer: Cardiovascular Systems, Inc. - 1225 Old Highway 8 NW, St. Paul, MN 55112 USA
Country of Origin: USA

Importer & distribution

Importer/Distributor: Abbott Laboratories

Registration dates

Issuance Date: July 14, 2025
Expiry Date: July 14, 2030

About this record

Access comprehensive regulatory information for Stealth 360™ Peripheral Orbital Atherectomy System in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number CMDR-2025-05157 and manufactured by Cardiovascular Systems, Inc. - 1225 Old Highway 8 NW, St. Paul, MN 55112 USA in USA. The device was registered on July 14, 2025.

This page provides complete registration details including manufacturer information, importer/distributor details (Abbott Laboratories), and regulatory compliance data from the official Philippines FDA medical device database. Pure Global AI offers free access to Philippines' complete medical device registry, helping global MedTech companies navigate FDA regulations efficiently.