|
Device | VENTAK PRIZM MODELS 1850 AND 1851 |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960040 |
Supplement Number | S038 |
Date Received | 11/26/2003 |
Decision Date | 12/24/2003 |
Product Codes |
KRG LWP |
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 LABELING CHANGES TO UPDATE BATTERY LONGEVITY INFORMATION. |