Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | TEMPO DR 2102 AND TEMP D 2902 |
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 | S015 |
Date Received | 11/06/1996 |
Decision Date | 11/27/1996 |
Withdrawal Date
|
06/20/2007 |
Product Code |
DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Other |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement MODIFICATION TO THE LABELING REGARDING THE PROPER INSERTION OF A LEAD INTO THE CONNECTOR PORT |
|
|