|
Device | ATTAIN LEAD/CONSULTA CRT-P/INSYNC III/SYNCRA CRT-PS |
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 | S132 |
Date Received | 07/06/2011 |
Decision Date | 08/04/2011 |
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 MANUFACTURING PROCESS CHANGE FOR THE DETERMINATION OF WORST CASE DEVICE REPRESENTATIVE FOR ETHYLENE OXIDE (EO) RESIDUAL TESTING FOR ETHYLENE OXIDE STERILIZATION. |