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 | MAVERICK MONORAIL |
Generic Name | Catheters, transluminal coronary angioplasty, percutaneous |
Regulation Number | 870.5100 |
Applicant | SCIMED LIFE SYSTEMS, INC. ONE SCIMED PLACE MAPLE GROVE, MN 55311-1566 |
PMA Number | P860019 |
Supplement Number | S170 |
Date Received | 03/13/2001 |
Decision Date | 04/05/2001 |
Reclassified Date
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10/08/2010 |
Product Code |
LOX |
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 CHANGES IN THE MANUFACTURING PROCESS FOR THE MAVERICK MONORAIL PRODUCT LINE TO INCLUDE THE USE OF A NON-TAPERED PRODUCTION MANDREL WITH BLUNT ENDS, AND ADDITIONAL PREVENTIVE MEASURES TO ENSURE THAT A THIN WALL CONDITION DOES NOT OCCUR IN THE INFLATION LUMEN, ICLUDING THE ADDITION OF A 100% VACUUM DECAY TEST FOR BOTH THE MAVERICK MONORAIL AND OVER-THE-WIRE PTCA CATHETERS. |
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