|
Device | USCI(R)TELESCOPE(TM) SINGLE OPERATOR BALLOON |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | MEDTRONIC IRELAND Parkmore Business Park West Galway |
PMA Number | P790017 |
Supplement Number | S060 |
Date Received | 12/17/1996 |
Decision Date | 12/15/1997 |
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 a new PTCA catheter line. The device, as modified, will be marketed under the trade name USCI(R) Telescope(TM) Single Operator Overl-the-Wire Balloon Catheter with Rely(TM) Balloon Material and Hydro/Pel(R) Coating and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. |