• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


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.
 
Trade NameDELTA PACEMAKER SYSTEM
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Namedual chamber, implantable pulse generator
ApplicantCARDIAC PACEMAKERS, INC.
PMA NumberP840068
Supplement NumberS025
Date Received04/06/1995
Decision Date11/20/1995
Product Code
LWP[ Registered Establishments with LWP ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for alternate manufacturing site for assembly of the external products (programmers, software modules/disks, external cardioverter defibrillators, and related accessories) which are used with cpi pacemaker and aicd systems. The proposed alternate manufacturing site (cardigan facility) is located at the following address:cpi cardigan facility, 599 cardigan road, shoreview, minnesota 55126.
-
-