• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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.
 
DeviceCONTAK RENEWAL FAMILY OF CRT-D
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pulse generator, pacemaker (non-crt)
Applicant
Boston Scientific Corp.
4100 hamline ave north
st. paul, MN 55112
PMA NumberP010012
Supplement NumberS183
Date Received06/19/2008
Decision Date07/30/2009
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE PROGRAMMER SOFTWARE APPLICATION MODEL 2845 VERSION 4.34 FOR THE CONTAK RENEWAL (MODEL H135), CONTAK RENEWAL 3 (MODELS H170, H175), CONTAK RENEWAL 3 HE (MODELS H177, H179), CONTAK RENEWAL 3 RF (MODELS H210, H215, H250, H255), AND CONTAK RENEWAL 3 RF HE (MODELS H217, H219, H257, H259).
-
-