|
Device | VARIOUS FAMILIES OF PACEMAKERS/ DEFIBRILLATORS/ CRTS |
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 | S054 |
Date Received | 03/26/2009 |
Decision Date | 05/14/2009 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC PUERTO RICO OPERATIONS CENTER (MPROC) IN VILLALBA, PUERTO RICO AS AN ALTERNATE MANUFACTURER FOR THE DEVICE. |