PMA P910077S037
- Device
- VENTAK PRIZM 2 VR/DR MODELS 1860/1861, VENTAK PRIZM VR/DR MODELS 1850/1851/1855/
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S037
- Product code
- LWS
- Decision date
- 2002-07-18
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR THE VENTAK PRIZM 2 VR/DR MODELS 1860/1861, VENTAK PRIZM VR/DR MODELS 1850/1851/1855/1856, VENTAK PRIZM VR/DR HE MODELS 1852/1853, VENTAK MINI IV MODELS 1790/1793/1796 AND VENTAK MINI III HE MODEL 1789. THESE DEVICES ARE INDICATED IN PATIENTS WHO HAVE HAD SPONTANEOUS AND/OR INDUCIBLE LIFE-THREATENING VENTRICULAR ARRHYTHMIAS AND THOSE WHO ARE AT HIGH RISK FOR DEVELOPING SUCH ARRHYTHMIAS. IN ADDITION, THESE DEVICES ARE INDICATED FOR PROPHYLACTIC TREATMENT OF PATIENTS WITH A PRIOR MYOCARDIAL INFARCTION AND AN EJECTION FRACTION (EF) <=30% (AS DEFINED IN THE CLINICAL STUDY SECTION).
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P910077S037B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- VENTAK PRIZM 2 VR/DR MODELS 1860/1861, VENTAK PRIZM VR/DR MODELS 1850/1851/1855/
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S037
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2002-07-18
- Decision code
- APPR
- Date received
- 2001-12-14
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE VENTAK PRIZM 2 VR/DR MODELS 1860/1861, VENTAK PRIZM VR/DR MODELS 1850/1851/1855/1856, VENTAK PRIZM VR/DR HE MODELS 1852/1853, VENTAK MINI IV MODELS 1790/1793/1796 AND VENTAK MINI III HE MODEL 1789. THESE DEVICES ARE INDICATED IN PATIENTS WHO HAVE HAD SPONTANEOUS AND/OR INDUCIBLE LIFE-THREATENING VENTRICULAR ARRHYTHMIAS AND THOSE WHO ARE AT HIGH RISK FOR DEVELOPING SUCH ARRHYTHMIAS. IN ADDITION, THESE DEVICES ARE INDICATED FOR PROPHYLACTIC TREATMENT OF PATIENTS WITH A PRIOR MYOCARDIAL INFARCTION AND AN EJECTION FRACTION (EF)