Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG
FDA premarket approval P980035/S603 · decided 2019-08-27
Approval details
- PMA number
- P980035
- Supplement
- S603
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2019-07-29
- Decision date
- 2019-08-27
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Change the functional test sequence from the XYZ tester to the Titan Device Tester single axis test system.
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