|
Device | SPRINT & SPRINT QUATTRO & SPRINT QUATTRO SECURE |
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 | S041 |
Date Received | 03/24/2008 |
Decision Date | 04/18/2008 |
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 ADDITION OF A PAPERLESS CHART RECORDER TO THE STERILIZATION OPERATIONS AT THE VILLALBA, PUERTO RICO MANUFACTURING FACILITY. |