|
Device | ALTO DR MODEL 614, ALTO VR MODEL 615, ALTO 2 DR MODEL 624 AND ALTO 2 VR MODEL 625 |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P980049 |
Supplement Number | S012 |
Date Received | 02/17/2004 |
Decision Date | 03/15/2004 |
Product Code |
MRM |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE LABELING TO INCLUDE A MORE ACCURATE BATTERY LONGEVITY DATA. |