VITATRON T60 DR AND T20 SR SYSTEMS
FDA premarket approval P990001/S015 · decided 2004-07-12
Approval details
- PMA number
- P990001
- Supplement
- S015
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VITATRON T60 DR AND T20 SR SYSTEMS
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- Medtronic, Inc.
- Date received
- 2004-06-03
- Decision date
- 2004-07-12
- Days to decision
- 39 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE VITATRON T60 DR AND T20 SR SYSTEMS, WHICH CONSIST OF THE FOLLOWING: 1) THE VITATRON T60 DR SYSTEM INCLUDES THE VITATRON T60 DR MODEL T60A1, THE VSF07/VSF08 VERSION 1.0 APPLICATION SOFTWARE, AND THE VITATRON DESKTOP MODEL VSH03/VSH04 VERSION 2.0 SR1. 2) THE VITATRON T20 SR SYSTEM INCLUDES THE VITATRON T20 SR MODEL T20A1, THE VSF07/VSF08 VERSION 1.0 APPLICATION SOFTWARE, AND THE VITATRON DESKTOP MODEL VSH03/VSH04 VERSION 2.0 SR1. NOTE: THE ABOVE REFERENCED APPLICATION SOFTWARE AND
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