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: ACS RX SOLARIS CORONARY DILATATION CATHETER
• Generic Name: Catheters, transluminal coronary angioplasty, percutaneous
• Regulation Number: 870.5100
• Applicant: ADVANCED CARDIOVASCULAR SYSTEMS, INC.; 26531 YNEZ RD.; TEMECULA, CA 92591
• PMA Number: P810046
• Supplement Number: S194
• Date Received: 12/04/1998
• Decision Date: 04/14/1999
• Reclassified Date: 10/08/2010
• Product Code: LOX
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
Approval for additional balloon sizes and an additional indication for use for the ACS RX Solaris(TM) Coronary Dilatation Catheter. The device as indicated for: a)balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. b) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction. c) Balloon dilatation of the ACS MULTI-LINK DUET(TM) stent after implantation. This indication applies to the following balloon sizes and stent lengths: Ballon Size:3.0-4.0mmx9mm Stent Length: 13mm 3.0-4.0mmx15mm 18mm 3.0-4.0mmx20mm 23mm 3.0-4.0mmx25mm 28mm