VITAITY HE MODELS T180 & T182, AND VENTAK PRIZM 2 VR MODEL 1860 AICDS
FDA premarket approval P960040/S072 · decided 2005-09-22
Approval details
- PMA number
- P960040
- Supplement
- S072
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VITAITY HE MODELS T180 & T182, AND VENTAK PRIZM 2 VR MODEL 1860 AICDS
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2005-08-11
- Decision date
- 2005-09-22
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL TO REPLACE THE EXISTING POLYIMIDE TUBING THAT PROVIDES INSULATION IN THE PULSE GENERATOR HEADER ASSEMBLY WITH POLYETHERETHERKE-TONE (PEEK) TUBING.
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