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. |
|
Device | MICRONY FAMILY PACEMAKERS |
Generic Name | Pulse-generator, single chamber, sensor driven, implantable |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P970013 |
Supplement Number | S012 |
Date Received | 09/27/2006 |
Decision Date | 10/25/2006 |
Product Code |
LWO |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement AUTOMATION OF DOWNLOADING MERLIN PREFERENCE FILES THROUGH THE FINAL SOFTWARE UPDATE PROCESS. |
|
|