PRO-Kinetic Energy Coronary Stent System
FDA PMAClass III (US FDA PMA)
by Biotronik AG
Identity
- Trade Name
- PRO-KINETIC ENERGY COBALT CHROMIUM (CoCr) CORONARY STENT SYSTEM FDA PMA
- Generic Name
- STENT, CORONARY FDA PMA
Identifiers
- PMA Number
- P160003 FDA PMA
- FDA Product Code
- MAF FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The PRO-Kinetic Energy Coronary Stent System is a cobalt chromium (CoCr) coronary stent indicated for improving coronary luminal diameter in patients with de novo or restenotic lesions in native coronary arteries. It is designed for use in reference vessel diameters ranging from 2.25 mm to 4.0 mm and lesion lengths up to 31 mm.
Supplied by Biotronik AG, this device is a Class III medical device authorized under FDA PMA (P160003). It is intended for percutaneous coronary intervention and is provided sterile for single-use only. Storage and handling should follow manufacturer specifications to maintain sterility and integrity prior to use.
Frequently asked questions
What is the reference vessel diameter range for the PRO-Kinetic Energy Coronary Stent System?
The reference vessel diameter range is from 2.25 mm to 4.0 mm, as specified in the approval documentation for treating de novo or restenotic lesions in native coronary arteries.
Is the PRO-Kinetic Energy Coronary Stent System supplied sterile and for single-use only?
Yes, the device is provided sterile and intended for single-use only, as is standard for coronary stent systems to ensure patient safety and prevent cross-contamination.
What regulatory authorization does the PRO-Kinetic Energy Coronary Stent System have?
The device has received FDA Premarket Approval (PMA) under number P160003, which was granted on February 14, 2017, following submission in January 2016.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P160003 | Class III | Active |
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Manufacturer
- Manufacturer
- Biotronik AG
Sources (1)
- FDA PMA P160003 24 fields · synced Sep 18, 2026