|
Device | SCIMED(R) RANGER(TM) PERCUTANEOUS CORONARY ANGIOPLASTY (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 | S126 |
Date Received | 07/16/1997 |
Decision Date | 08/12/1997 |
Reclassified Date
|
10/08/2010 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR ADDITIONAL BALLOON SIZES (22 MM AND 30 MM LENGTHS WITH BALLOON SIZES OF 2.5 MM UP TO 4.0 MM IN 1/4 SIZES) FOR THE SCIMED(R) QUANTUM RANGER(TM) PTCA CATHETER. |