|
Device | TEMPO PULSE GENERATORS |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 15900 Valley View Ct. Sylmar, CA 91342 |
PMA Number | P900070 |
Supplement Number | S022 |
Date Received | 03/06/1998 |
Decision Date | 09/03/1998 |
Withdrawal Date
|
06/20/2007 |
Product Code |
DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for modifications to the approved labeling including the: addition of a "Cellular Tested" logo and associated language in the Patient and Physician manuals specifying those cellular telephone protocols for which testing has been performed and shown no interaction. |