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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.
Classification Namedrug eluting permanent left ventricular (lv) pacemaker electrode
PMA NumberP060039
Supplement NumberS003
Date Received07/21/2008
Decision Date01/16/2009
Product Code
OJX[ Registered Establishments with OJX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for 1) use of new analytical methods for assay, content uniformity and identity testing; 2) tightening of the assay specification relative to the label claim; 3) modification of the elution specification with an additional time point and updated acceptance criteria; 4) modification of the residual solvent specification; 5) modification of the appearance specification: 6) use of a new laboratory for release and stability testing; 7) use of new assay, content uniformity, identification, elution and related substance analytical test methods developed at the new laboratory; 8) use of the approved appearance/ description and residual solvents test methods at the new laboratory; 9) use of the new laboratory sterility test method; and 10) update of the model 4195 lead shelf life to 12 months and agreement that drug stability data at 18 months are acceptable.