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 | PERCUTANEOUS CORONARY DILATATION CATHETERS |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Applicant | ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 YNEZ RD. TEMECULA, CA 92591 |
PMA Number | P810046 |
Supplement Number | S209 |
Date Received | 05/17/2001 |
Decision Date | 08/22/2001 |
Reclassified Date
|
10/08/2010 |
Product Codes |
DYG LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATIONS IN THE INSTRUCTIONS FOR USE BOOKLETS OF THE POWERSAIL(TM), HIGHSAIL(TM), CROSSSAIL(TM), OPENSAIL(TM), ACS OTW PHOTON(TM), ACS RX GEMINI(TM), AND ACS RX ESPRIT PTCA CATHETERS. |
|
|