|
Device | INSYNC FAMILIES OF ICD & CONCERTO ICD |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S079 |
Date Received | 09/17/2007 |
Decision Date | 02/08/2008 |
Product Code |
NIK |
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 FOR CHANGING THE SURFACTANT USED TO HELP DISPERSE POLYTETRAFLUOROETHY-LENE (PTFE) DURING THE BATTERY MANUFACTURING PROCESS. |