|
Device | SCIMED JAZ RANGER PERCUTANEOUS TRANSLUMINAL 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 | S135 |
Date Received | 11/24/1997 |
Decision Date | 12/22/1997 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement Approval for: 1)the addition of balloon diameters of 4.5 mm and 5.0 mm to the currently approved 15 mm length of the NC REBEL(TM) PTCA Catheter, and 2) an additional balloon length of 30 mm with balloon diameters of 2.5 mm up to 4.0 mm in 1/4 mm increments for the NC REBEL(TM) PTCA Catheter. |