|
Device | TELESCOPE PTCA BALLOON 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 | S064 |
Date Received | 01/20/1998 |
Decision Date | 02/12/1998 |
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 |
Approval Order Statement Approval to sell the USCI(R) Telescope(TM) Balloon Dilatation Catheter with Hydro/Pel(R) Coating to Cordis Corp. for distribution. |