Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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
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 NameSOLUS (R) MODELS 2002,2003,SYNCHRONY(R)2022,2023
Classification Nameimplantable pacemaker pulse-generator
Generic Namepulse generator
Regulation Number870.3610
ApplicantSIEMENS-PACESETTER, INC.
PMA NumberP880086
Supplement NumberS021
Date Received03/11/1993
Decision Date06/04/1993
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason location change - other
Expedited Review Granted? No
Combination Product No
-
-