|
Device | MAVERICK MONORAIL/OVER THE WIRE PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PICA) CATHETERS |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | SCIMED LIFE SYSTEMS, INC. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P860019 |
Supplement Number | S181 |
Date Received | 04/10/2002 |
Decision Date | 04/24/2002 |
Reclassified Date
|
10/08/2010 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ALTERNATE MANUFACTURING PROCESS TO PRODUCE BALLOONS FOR THE MAVERICK MONORAIL PTCA CATHETER AND THE MAVERICK OTW PTCA CATHETER. THE ALTERNATE PROCESS AFFECTS ONLY THE METHOD OF STRETCHING THE BALLOON TUBING PRIOR TO MOLDING THE BALLOON. |