|
Device | SCIMED REBEL 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 | S138 |
Date Received | 02/25/1998 |
Decision Date | 04/06/1998 |
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 additional balloon lengths of 16 mm and 18 mm with balloon sizes of 2.5 mm up to 4.0 mm in 1/4 mm increments for the SCIMED(R) NC Ranger(TM) PTCA Catheter. |