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 | DISCRETE TECHNOLOGY(TM)OVER-THE-WIRE/RAPID EXCHANGE CORONARY STENT SYSTEM |
Generic Name | STENT, CORONARY |
Applicant | MEDTRONIC IRELAND Parkmore Business Park West Galway |
PMA Number | P970035 |
Supplement Number | S024 |
Date Received | 02/20/2001 |
Decision Date | 03/19/2001 |
Withdrawal Date
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10/18/2010 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE FROM AN OIL-BASE COOLANT USED DURING RING MACHING PROCESS TO A WATER-BASE COOLANT, AND PROPOSES TO CHANGE THE ALCOHOL AND HFE SOLVENT CLEANER USED DURING RING MACHINING TO A WATER-BASE CLEANING SOLUTION FOR BOTH THE S670 AND S660 PRODUCTS. |
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