PROGRAMMER SOFTWARE APPLICATION MODEL 2812, VERSION 1.4
FDA premarket approval P960040/S083 · decided 2007-03-23
Approval details
- PMA number
- P960040
- Supplement
- S083
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PROGRAMMER SOFTWARE APPLICATION MODEL 2812, VERSION 1.4
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2005-08-25
- Decision date
- 2007-03-23
- Days to decision
- 575 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR VITALITY AVT PROGRAMMER SOFTWARE (SW) MODEL 2812V1.4 AND THE APPLICABLE FIRMWARE FOR USE ON TE MODEL 2920 PROGRAMMER.
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