(34 days)
The Atlantis™ SR and Atlantis™ SR PLUS Imaging Catheters are intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound is indicated in patients who are candidates for transluminal coronary interventional procedures.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to Boston Scientific Corporation for their Atlantis™ SR and Atlantis™ SR PLUS Imaging Catheters. This letter approves the marketing of the device based on substantial equivalence to a legally marketed predicate device.
Crucially, this document does NOT contain a study or data proving the device meets specific acceptance criteria.
The 510(k) process in 2004 primarily relied on demonstrating substantial equivalence to a predicate device, meaning it's as safe and effective as a device already on the market. It often does not require detailed performance studies with acceptance criteria in the same way a PMA (Premarket Approval) would.
Therefore, I cannot provide the requested information from the given text because the text does not include a study or its results. It is simply an FDA clearance letter.
To fully answer your prompt, I would need a document detailing the studies conducted, their methodology, and results, which are typically found in the 510(k) submission itself, not the FDA's clearance letter.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).