|
Device | MAVERICK MONORAIL PTCA CATHETER SYSTEM AND MAVERICK2 MONORAIL PTCA CATHETER SYSTEM |
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 | S200 |
Date Received | 05/12/2004 |
Decision Date | 06/10/2004 |
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 CHANGE IN THE MANUFACTURING PROCESS TO PROPOSE ALTERNATIVE PARAMETERS FOR LASER WELDING OF THE PORT BOND ON THE MAVERICK AND MAVERICKRAIL PTCA CATHETER SYSTEMS. |