Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER
• Generic Name: Coronary drug-eluting stent
• Applicant: CORDIS CORP.; 6500 Paseo Padre Parkway; Fremont, CA 94555
• PMA Number: P020026
• Supplement Number: S014
• Date Received: 07/18/2005
• Decision Date: 05/17/2006
• Withdrawal Date: 08/28/2020
• Product Code: NIQ
• Advisory Committee: Cardiovascular
• Supplement Type: Real-Time Process
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement  
APPROVAL TO IMPLEMENT NEW ORTHOGONAL METHODS TO QUANTITATE DRUG CONTENT, IMPURITIES AND DEGRADATION PRODUCTS FOR THE CYPHER STENT. BASED UPON THESE NEW METHODS, YOU HAVE ALSO REQUESTED APPROVAL FOR NEW SPECIFICATIONS FOR IMPURITIES AND DEGRADATION PRODUCTS FOR THE CYPHER STENT AT FINISHED GOODS RELEASE TESTING AND ON STABILITY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVERY SYSTEM AND IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC DISEASE DUE TO DISCRETE DE NOVO LESIONS OF LENGTH <= 30MM IN NATIVE CORONARY ARTERIES WITH REFERENCE VESSEL DIAMETER OF >= 2.5 MM TO <= 3.5 MM.