|
Device | MEDTRONIC SPRINT QUATTRO SECURE DF4 LEAD MODEL 6947M |
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 | S086 |
Date Received | 02/23/2012 |
Decision Date | 03/21/2012 |
Product Code |
LWS |
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 ADD SPRINT QUATTRO SECURE LEAD MODEL 6974M TO PREVIOUSLY APPROVED 30-DAY NOTICE SUBMISSIONS REGARDING STERILE PACKAGING PROCESS CHANGES. |