|
Device | MAVERICK 2 MONORAIL AND MAVERICK OTW PTCA 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 | S201 |
Date Received | 11/01/2004 |
Decision Date | 05/11/2005 |
Reclassified Date
|
10/08/2010 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGE IN THE MANUFACTURING PROCESS FOR FORMING THE FOLDING THE BALLOON WINGS FROM A MANUAL PROCESS TO AN AUTOMATED PROCESS. |