|
Device | MEDTRONIC SPRINT FIDELIS LEAD |
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 | S037 |
Date Received | 05/15/2007 |
Decision Date | 07/03/2007 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR DESIGN AND MANUFACTURING CHANGES TO IMPROVE THE DF-1 LEG STRENGTH AND HANDLING CHARACTERISTICS OF SPRINT FIDELIS LEADS. |