MODEL 2725 VENTAK PRIZM DIAGNOSTIC/RESTORATION TOOL
FDA premarket approval P960040/S022 · decided 2001-06-13
Approval details
- PMA number
- P960040
- Supplement
- S022
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 2725 VENTAK PRIZM DIAGNOSTIC/RESTORATION TOOL
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2001-05-23
- Decision date
- 2001-06-13
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- 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.
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