• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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.
 
Trade NameMEDTRONIC ARRHYTHMIA MANAGEMENT DEVICES INCLUDING MODEL 7221B/CX/D/E MICRO JEWEL DEVICE USED WITH CPI ENDOTAK
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameautomatic implantable cardioverter/defibrillator
ApplicantMEDTRONIC VASCULAR
PMA NumberP900061
Supplement NumberS029
Date Received11/18/1996
Decision Date03/07/1997
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for jewel(r) models 7219 b/d/e, 7202 d/e, 7220 b/d/e, 7221 b/cx/d/e microjewel(tm), and 7223 micro jewel ii(tm) with endotak(r) dsp lead models 0092, 0093, 0094, 0096, 0097, 0123, and 0125 and the model 6836 y connector.
-
-