Orion: Astra XT DR MIR IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT SR MRI IPG, AZURE S DR MRI IPG, AZURE S SR
FDA premarket approval P980035/S521 · decided 2017-10-24
Approval details
- PMA number
- P980035
- Supplement
- S521
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Orion: Astra XT DR MIR IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT SR MRI IPG, AZURE S DR MRI IPG, AZURE S SR
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2017-09-28
- Decision date
- 2017-10-24
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Change the inspection method for radiopaque presence and connector mix inspections from a human visual inspection to a semi-automated inspection using a vision system.
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