ADVISA DR IPR, ADVISA DR MRI IPG
FDA premarket approval P980035/S317 · decided 2013-05-15
Approval details
- PMA number
- P980035
- Supplement
- S317
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ADVISA DR IPR, ADVISA DR MRI IPG
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2013-03-27
- Decision date
- 2013-05-15
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR TWO MINOR DESIGN CHANGES TO THE L310 INTEGRATED CIRCUIT FOR THE ADVISA DR MRI DEVICE.
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