KAPPA,SIGMA,ADAPTA,SENSA,ADVISA,REVO MRI,ENRHYTHM MRI,RELIA,VERSA,AND ENPULSE FAMILIES OF IPGS
FDA premarket approval P980035/S290 · decided 2012-09-25
Approval details
- PMA number
- P980035
- Supplement
- S290
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- KAPPA,SIGMA,ADAPTA,SENSA,ADVISA,REVO MRI,ENRHYTHM MRI,RELIA,VERSA,AND ENPULSE FAMILIES OF IPGS
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2012-08-24
- Decision date
- 2012-09-25
- Days to decision
- 32 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR FIRMWARE UPDATES TO THE MODEL 2490C MEDTRONIC CARELINK REMOTE HOME MONITOR, THE MODEL 2020A MEDTRONIC CARDIOSIGHT READER, AND THE MODEL 2020B CARELINK EXPRESS MONITOR.
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