Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM MEDTRONIC 18K, 18K WITH TIP MARKER, 14K, 14K LONG, PANTHER 30 AND 40 |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | MEDTRONICS INTERVENTIONAL VASCULAR 3576 UNO CAL PLACE SANTA ROSA, CA 95403 |
PMA Number | P870036 |
Supplement Number | S037 |
Date Received | 11/01/1995 |
Decision Date | 12/07/1995 |
Withdrawal Date
|
06/09/2008 |
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 THE USE OF AN ALTERNATE ADHESIVE ON HTE REFERENCED PTCA CATHETERS (VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM - MEDTRONIC 18K, 18K WITH TIP MARKER, 14K, 14K LONG, PANTHER, PANTHER 30, AND PANTHER 40 PTCA CATHETERS) |
|
|