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 | USCI(R) SPRINT(TM) BALL. DIL. CATH. W/PRO/PEL COAT |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | MEDTRONIC IRELAND Parkmore Business Park West Galway |
PMA Number | P790017 |
Supplement Number | S040 |
Date Received | 02/21/1991 |
Decision Date | 12/06/1991 |
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 |
|
|