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

510(k) Premarket Notification
  • 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
Device Classification Name Implantable Pacemaker Pulse-Generator
510(k) Number K932884
Device Name MINIX/MINIX ST PULSE GENERATORS
Applicant
Medtronic Vascular
7000 Central Ave. N.E
Minneapolis,  MN  55432
Applicant Contact JOHN M OTTO
Correspondent
Medtronic Vascular
7000 Central Ave. N.E
Minneapolis,  MN  55432
Correspondent Contact JOHN M OTTO
Regulation Number870.3610
Classification Product Code
DXY  
Date Received06/14/1993
Decision Date 05/02/1994
Decision SE - Postmarket Surveillance Required (SESP)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-