ASTRA XT SR MRI SURESCAN, ASTRA XT DR MRI SURESCAN, ASTRA S SR MRI SURESCAN, ASTRA S DR MRI SURESCAN, SOFTWARE MODEL
FDA premarket approval P980035/S486 · decided 2017-05-06
Approval details
- PMA number
- P980035
- Supplement
- S486
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ASTRA XT SR MRI SURESCAN, ASTRA XT DR MRI SURESCAN, ASTRA S SR MRI SURESCAN, ASTRA S DR MRI SURESCAN, SOFTWARE MODEL
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2016-12-06
- Decision date
- 2017-05-06
- Days to decision
- 151 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for the Astra SR and DR Implantable Pulse Generators.
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