Adapta, Versa, and Sensia IPG, Advisa SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG,
FDA premarket approval P980035/S591 · decided 2019-05-20
Approval details
- PMA number
- P980035
- Supplement
- S591
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Adapta, Versa, and Sensia IPG, Advisa SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG,
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2019-04-29
- Decision date
- 2019-05-20
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Addition of the Relative Humidity monitoring process to monitor the internal relative humidity in the device.
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