VENTAK PRIZM 2 VR/DR MODELS 1860/1861, VENTAK PRIZM VR/DR MODELS 1850/1851/1855/
FDA premarket approval P910077/S037 · decided 2002-07-18
Approval details
- PMA number
- P910077
- Supplement
- S037
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VENTAK PRIZM 2 VR/DR MODELS 1860/1861, VENTAK PRIZM VR/DR MODELS 1850/1851/1855/
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2001-12-14
- Decision date
- 2002-07-18
- Days to decision
- 216 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- Yes
- Location
- St Paul, MN
- 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 MYOCA
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