|
Device | MAVERICK OVER THE WIRE PTCA CAHTHETER |
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 | S177 |
Date Received | 10/05/2001 |
Decision Date | 11/08/2001 |
Reclassified Date
|
10/08/2010 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE ADDITION OF A QUALITY CDONTROL INSPECTION STEP FOR MARKER BAND PLACEMENT DURING THE MANUFACTURING PROCESS OF THE MAVERICK OVER THE WIRE PTCA CATHETER. |