|
Device | VARIOUS FAMILIES OF PACEMAKERS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P980035 |
Supplement Number | S114 |
Date Received | 09/08/2008 |
Decision Date | 02/04/2009 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO CHANGE THE PRODUCTION TEST LIMITS FOR THE SIN2 SENSE DETECT THRESHOLD IN THE NON-PACING MODE. |