|
Device | NC BIG RANGER PTCA CATHETER |
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 | S192 |
Date Received | 11/25/2002 |
Decision Date | 12/17/2002 |
Reclassified Date
|
10/08/2010 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO MODIFY THE LABELING TO EXTEND THE BALLOON COMPLIANCE CHART DIAMETERS TO HUNDREDTHS AND TO ADD A NOTE TO THE DIRECTIONS FOR USE STATING THE RECOMMENDED MINIMUM GUIDE CATHETER LUMEN INNER DIAMETER. |