ADVISA SR MRI A3SR01; IMPLANTABLE PULSE GENERATOR, DR MRI A2DR01 IMPLANTABLE PULSE GENERATOR, SOFTWARE MODEL 9995
FDA premarket approval P980035/S374 · decided 2015-03-19
Approval details
- PMA number
- P980035
- Supplement
- S374
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ADVISA SR MRI A3SR01; IMPLANTABLE PULSE GENERATOR, DR MRI A2DR01 IMPLANTABLE PULSE GENERATOR, SOFTWARE MODEL 9995
- Generic name
- Pulse generator, permanent, implantable
- Applicant
- Medtronic, Inc.
- Date received
- 2014-04-23
- Decision date
- 2015-03-19
- Days to decision
- 330 days
- Decision code
- APPR
- Product code
- NVZ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE ADVISA SR MRI A3SR01 IMPLANTABLE PULSE GENERATOR IN COMBINATION WITH THE CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI TO BE MARKETED AS THE ADVISA SR MRI SURESCAN. IN ADDITION YOU REQUESTED APPROVAL FOR MODIFICATIONS TO THE ADVISA SR MRI AND ADVISA DR MRI SOFTWARE APPLICATION MODEL 9995.
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