|
Device | TEMPO FAMILY OF 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 | S024 |
Date Received | 10/06/1998 |
Decision Date | 10/29/1998 |
Withdrawal Date
|
06/20/2007 |
Product Code |
DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for an extension of product shelf life from 12 months to 18 months. |