|
Device | MEDTRONIC SPRINT FIDELIS LEADS MODELS,6949,6948,6931,6930 |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P920015 |
Supplement Number | S032 |
Date Received | 09/02/2005 |
Decision Date | 12/01/2005 |
Product Code |
LWS |
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 | Yes |
Approval Order Statement APPROVAL TO CHANGE THE AERATION TIME FOLLOWING STERILIZATION OF THE SPRINT FIDELIS LEADS. |