|
Device | SCIMED(R) 10MM & 20MM NC BANDIT(TM) 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 | S110 |
Date Received | 01/19/1996 |
Decision Date | 02/26/1996 |
Reclassified Date
|
10/08/2010 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR:1)10 AND 20 MM BALLOON LENGTHS; 2) 2.0 AND 2.25 DIAMETER BALLOONS IN THE 20 MM LENGTH; AND 3) THE USE OF AN EPOXY ADHESIVE FORTHE MANIFOLD BOND |