|
Device | ACS CORONARY DILATATION CATHETERS (INDICATION) |
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 | S170 |
Date Received | 11/25/1996 |
Decision Date | 05/13/1997 |
Reclassified Date
|
10/08/2010 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | Yes |
Combination Product | No |
Approval Order Statement APPROVAL FOR: A) THE ADDITION OF THE INDICATION "BALLOON DILATATION OF A CORONARY ARTERY OCCLUSION OFR THE PURPOSE OF RESTORING CORONARY FLOW IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION"; AND (B) OTHER MODIFICATIONS OT THE CURRENT LABEL TO REFLECT THIS NEW INDICATION. |