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. |
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Device | D114S/NEPTUNE X-ACT OVER-THE-WIRE BALLOON DILATATION 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 | S072 |
Date Received | 07/14/2000 |
Decision Date | 07/24/2000 |
Reclassified Date
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10/08/2010 |
Product Code |
LOX |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE IN SUPPLIER OF THE HIGH MOLECULAR WEIGHT HIGH-DENSITY POLYETHYLENE INNER SHAFT USED IN AVE IRELAND'S MANUFACTURING NEPTUNE(TM) X-ACT(R) AND D114S OVER-THE-WIRE PTCA CATHETERS OPERATIONS. |
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