Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG
FDA premarket approval P980035/S618 · decided 2020-05-08
Approval details
- PMA number
- P980035
- Supplement
- S618
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2020-02-25
- Decision date
- 2020-05-08
- Days to decision
- 73 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for RAMware updates to ICD, CRT-D, CRT-P, and IPG devices and corresponding updates to Medtronic CareLink Programmer Model 2090 and Encore Programmer Model 29901 device applications SW034, SW035, SW030, and SW040.
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|---|---|---|
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