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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameRESOLUTE MICROTRAC/RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
Classification Namecoronary drug-eluting stent
ApplicantMEDTRONIC VASCULAR
PMA NumberP110013
Date Received04/01/2011
Decision Date02/17/2012
Product Code
NIQ[ Registered Establishments with NIQ ]
Docket Number 12M-0177
Notice Date 03/07/2012
Advisory Committee Cardiovascular
Clinical Trials NCT00248079
NCT00617084
NCT00726453
NCT00752128
NCT00927940
NCT01150500
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Approval for the resolute microtrac zotarolimus-eluting coronary stent system and resolute integrity zotarolimus-eluting coronary stent systems. These devices are indicated for improving coronary luminal diameters in patients, including those with diabetes mellitus, with symptomatic ischemic heart disease due to de novo lesions of length 27 <= mm in native coronary arteries with reference vessel diameters of 2. 25 mm to 4. 2 mm.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S007 S008 S009 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S019 
S020 S021 S022 S023 S024 S025 S026 S027 S028 
S029 S030 S031 S032 S033 S034 S035 S036 S037 
S038 S039 S040 S043 S044 S045 
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