The Spectranetics Corp.
Country not established
- Devices
- 1
What The Spectranetics Corp. makes
The Spectranetics Corp. manufactures drug-coated angioplasty balloons, including the STELLAREX 0.035 OTW model, designed for percutaneous coronary interventions. These devices are intended for use in treating coronary artery disease by delivering medication to the vessel wall during angioplasty procedures. The portfolio focuses on intravascular solutions for improving blood flow in narrowed or blocked arteries.
The company’s products fall under Class III regulatory classification in the US, requiring a Premarket Approval Application (PMA) through the FDA. These devices are listed in the FDA’s PMA registry. The manufacturer is based in the United States.
Catalogue
- Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does The Spectranetics Corp. have in the registry?
The registry currently lists 1 device for The Spectranetics Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list The Spectranetics Corp.'s devices?
Among its 1 most recently registered device, The Spectranetics Corp. has devices listed in FDA PMA (1 device).
What risk classes do The Spectranetics Corp.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for The Spectranetics Corp.'s devices are Class III. Each device page shows its own class and authorisation.
What are the newest devices from The Spectranetics Corp. in the registry?
The most recently registered devices listed for The Spectranetics Corp. include STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON.