|
Device | PROCROSS RELY SP PTCA CATHETER |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | MEDTRONIC IRELAND Parkmore Business Park West Galway |
PMA Number | P790017 |
Supplement Number | S063 |
Date Received | 07/31/1997 |
Decision Date | 08/26/1997 |
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 the addition of ten models to your currently marketed line of USCI(R) ProCross(TM) Over-the-Wire Balloon Dilatation Catheters with Hydro/Pel(R) Coating. The device, as modified, will be marketed under the trade name USCI(R) ProCross(TM) SP Over-the-Wire Balloon Dilatation Catheters with 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. |