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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSPRINTER OVER-THE-WIRE (OTW) BALLOON DILATATION CATHETER (MULTIPLE MODEL NUMBERS FOR THE 1.5 MM TO 4.0 MM DIAMETERS)
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter
Regulation Number870.5100
ApplicantMEDTRONIC VASCULAR GALWAY LIMITED
PMA NumberP790017
Supplement NumberS081
Date Received12/26/2003
Decision Date06/23/2004
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for minor design, packaging and labeling changes to the stormer otw ballon dilatation catheter including the addition of 6 mm and 12 mm balloon lengths. The device, as modified, will be marketed under the trade name sprinter otw balloon dilatation catheter and is indicated as follows: for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The sprinter otw balloon dilatation catheter (balloon models 2. 5 mm - 4. 0 mm) is also indicated for post-delivery expansion of balloon expandable stents. Note: bench testing was conducted with the sprinter otw balloon dilatation catheter and marketed balloon expandable stents. Consideration should be taken when this device is used with different manufacturers' stents due to differences in stent design.
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