Cobra PzF NanoCoated Coronary Stent System
FDA PMAEUDAMEDClass III (US FDA PMA)
Identity
- Trade Name
- COBRA PzF Coronary Stent System EUDAMEDCOBRA PzF NanoCoated Coronary Stent System FDA PMA
- Generic Name
- STENT, CORONARY FDA PMA
- Device Name
- COBRA PzF Coronary Stent System EUDAMED
- Model / Reference
- 170-01-30030 EUDAMED170-01-25030 EUDAMED170-01-27512 EUDAMED170-01-30024 EUDAMED170-01-25024 EUDAMED170-01-25008 EUDAMED170-01-25015 EUDAMED170-01-40008 EUDAMED170-01-27518 EUDAMED170-01-27530 EUDAMED170-01-35008 EUDAMED170-01-40015 EUDAMED170-01-35024 EUDAMED170-01-40030 EUDAMED170-01-30008 EUDAMED170-01-30012 EUDAMED170-01-35030 EUDAMED170-01-25018 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00879397007370 EUDAMED00879397007257 EUDAMED00879397007271 EUDAMED00879397007363 EUDAMED00879397007240 EUDAMED00879397007202 EUDAMED00879397007226 EUDAMED00879397007448 EUDAMED00879397007295 EUDAMED00879397007318 EUDAMED00879397007387 EUDAMED00879397007462 EUDAMED00879397007424 EUDAMED00879397007493 EUDAMED00879397007325 EUDAMED00879397007332 EUDAMED00879397007431 EUDAMED00879397007233 EUDAMED
- Basic UDI-DI
- B-00879397007370 EUDAMEDB-00879397007257 EUDAMEDB-00879397007271 EUDAMEDB-00879397007363 EUDAMEDB-00879397007240 EUDAMEDB-00879397007202 EUDAMEDB-00879397007226 EUDAMEDB-00879397007448 EUDAMEDB-00879397007295 EUDAMEDB-00879397007318 EUDAMEDB-00879397007387 EUDAMEDB-00879397007462 EUDAMEDB-00879397007424 EUDAMEDB-00879397007493 EUDAMEDB-00879397007325 EUDAMEDB-00879397007332 EUDAMEDB-00879397007431 EUDAMEDB-00879397007233 EUDAMED
- PMA Number
- P160014 FDA PMA
- FDA Product Code
- MAF FDA PMA
- EMDN Code
- P0704020102 COATED CORONARY STENTS EUDAMED
Classification
- Device Class
- Class III EUDAMEDFDA PMA
- Market of Registration
- Netherlands EUDAMED
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APWD FDA PMA
Clinical & Handling
Sterile
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Cobra PzF NanoCoated Coronary Stent System is a coronary stent designed to improve coronary luminal diameter in patients with symptomatic ischemic heart disease. It is indicated for use in patients with de novo lesions in native coronary arteries, including those with diabetes mellitus.
This system is intended for patients eligible for percutaneous transluminal coronary angioplasty. It is suitable for vessels with a reference diameter between 2.5 mm and 4.0 mm and lesion lengths of less than 24 mm. The device is authorized under FDA PMA P160014 and MDD regulations.
Frequently asked questions
What is the primary indication for the Cobra PzF Stent System?
The system is indicated for improving coronary luminal diameter in patients suffering from symptomatic ischemic heart disease, specifically for de novo lesions in native coronary arteries.
Which patient populations can be treated with this stent?
The device is indicated for patients eligible for percutaneous transluminal coronary angioplasty, including those diagnosed with diabetes mellitus.
What are the vessel size requirements for this device?
The Cobra PzF Stent System is designed for use in native coronary arteries with a reference vessel diameter ranging from 2.5 mm to 4.0 mm and lesion lengths measuring less than 24 mm.
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. Sources consulted: COBRA PzF™ coronary stent in clinical and preclinical studies, [PDF] Patient Information Guide - accessdata.fda.gov, First patient enrolled in trial of the COBRA PzF nanocoated ..., 9-Month Clinical and Angiographic Outcomes of the COBRA ..., Final 5-Year Results Revealed From CeloNova's PzF SHIELD ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | European Union | MDD | — | Class III | Pending data |
| FDA PMA | United States | FDA_PMA | P160014 | Class III | Active |
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Manufacturer
- Manufacturer
- Celonova Biosciences, Inc.
Sources (19)
- FDA PMA P160014 24 fields · synced Sep 18, 2026
- EUDAMED 90279dae-0087-4c9b-8bc8-2a5c6c022983 61 fields · synced Jul 8, 2026
- EUDAMED b9cfff48-5c8f-42a0-bdb1-203b0dd2955f 61 fields · synced Jul 9, 2026
- EUDAMED 4883e7a2-da74-4950-a840-2f3932fc3b17 61 fields · synced Jul 9, 2026
- EUDAMED 98e14b77-ec46-426f-a4c2-fc7d58619641 61 fields · synced Jul 10, 2026
- EUDAMED 88963ad0-4aee-4ca1-96c2-886b06e21036 61 fields · synced Jul 12, 2026
- EUDAMED 51bfb194-d41b-4a2f-8ceb-b95b5572cd80 61 fields · synced Jul 12, 2026
- EUDAMED 6435c0fe-b95d-48b1-b2bb-28e70743164e 61 fields · synced Jul 12, 2026
- EUDAMED 3eacb277-420a-4ef4-8197-d06b6ba3a022 61 fields · synced Jul 13, 2026
- EUDAMED cb0e7607-b494-4d88-97ad-c8af0c56db66 61 fields · synced Jul 13, 2026
- EUDAMED ed03528b-2b96-41f8-9bb3-7360dbdde661 61 fields · synced Jul 14, 2026
- EUDAMED 719e1e36-a582-4956-9aec-15e54a3999dd 61 fields · synced Jul 16, 2026
- EUDAMED 3951403f-c7f7-4bc8-a9c0-3ca92a97d172 61 fields · synced Jul 16, 2026
- EUDAMED bf3e335e-eea6-49df-bc69-a28ed79824e9 61 fields · synced Jul 16, 2026
- EUDAMED b307ef71-7db5-49a5-a551-e69648433445 61 fields · synced Jul 19, 2026
- EUDAMED f6f63979-6520-4a63-9772-9799afafb988 61 fields · synced Jul 21, 2026
- EUDAMED 2815dad8-df24-4d42-98c0-855b2fb41d8c 61 fields · synced Jul 22, 2026
- EUDAMED 1c142924-f904-4dcc-b400-85216ee17296 61 fields · synced Jul 24, 2026
- EUDAMED 8b473344-e9cc-45e3-9ecc-aacb57887c34 61 fields · synced Jul 29, 2026