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Device | MODEL 2725 VENTAK PRIZM DIAGNOSTIC/RESTORATION TOOL |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960040 |
Supplement Number | S022 |
Date Received | 05/23/2001 |
Decision Date | 06/13/2001 |
Product Codes |
KRG LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODEL 2725 VENTAK(R) PRIZM(TM) DIAGNOSTIC/RESTORATION TOOL VERSION 1.5. THE DEVICE IS INDICATED TO DIAGNOSE AND RESTORE TO FACTORY NORMAL SETTINGS VENTAK PRIZM/PRIZM HE DEVICES THAT HAVE BEEN AFFECTED BY A SPECIFIC MEMORY INTERATION THAT RESULTS IN SAFETY MODE. |