|
Device | CONSULTA CRT-P, SYNCRA CRT-P |
Generic Name | Drug eluting permanent left ventricular (lv) pacemaker electrode |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P010015 |
Supplement Number | S191 |
Date Received | 03/04/2013 |
Decision Date | 03/20/2013 |
Product Code |
OJX |
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 ADDITION OF A BATTERY BURN-IN PROCESS TO THE UNIVERSAL BURN-IN TEST SYSTEM PROCESSING AND INSPECTION METHODS AND ASSOCIATED SOFTWARE. |