MODEL 2090 MEDTRONIC CARELINK PROGRAMMER
FDA premarket approval P980035/S138 · decided 2009-07-28
Approval details
- PMA number
- P980035
- Supplement
- S138
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 2090 MEDTRONIC CARELINK PROGRAMMER
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2009-06-17
- Decision date
- 2009-07-28
- Days to decision
- 41 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR VERSION 2.2 OF THE MODEL 9986 DESKTOP/BOSS SOFTWARE FOR THE MEDTRONIC CARELINK PROGRAMMER.
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