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) | 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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceADVISA SR MRI
Generic NamePulse generator, permanent, implantable
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP980035
Supplement NumberS427
Date Received06/03/2015
Decision Date06/27/2015
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
FOUR (4) MANUFACTURING CHANGES FOR THE ADVISA SR MRI MODEL A3SR01 THAT HAD BEEN PREVIOUSLY APPROVED FOR PREDECESSOR DEVICES TO ALIGN THE ADVISA SR MRIMANUFACTURING PROCESS WITH THE PREDECESSOR DEVICE MANUFACTURING PROCESSES:1) IC SUPPLIER PROCESS FLOW UPDATE TO BICMOS;1) ADDITIONAL LEAK TEST STATION FOR MEDIUM RATE BATTERY; 2) ADDITIONAL WORK STATIONS AT MEDIUM RATE BATTERY SUPPLIER; AND3) FINAL PACK EQUIPMENT IMPLEMENTATION (COQUILPULS LINE) ¿ PHASE II.
-
-