PMA P980035S481
- Device
- Advisa MRI DR /SR SureScan Implantable Pulse Generators (IPGs)
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S481
- Product code
- NVZ
- Decision date
- 2017-04-25
- Classification
- Pulse Generator, Permanent, Implantable
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- Approval of 1.5 and 3T MR Conditional Labeling for SelectSecure MRI SureScan Lead Model 3830.
Current openFDA PMA Record#
- Device
- Advisa MRI DR /SR SureScan Implantable Pulse Generators (IPGs)
- Applicant
- Medtronic, Inc.
- PMA number
- P980035
- Supplement
- S481
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2017-04-25
- Decision code
- APPR
- Date received
- 2016-11-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval of 1.5 and 3T MR Conditional Labeling for SelectSecure MRI SureScan Lead Model 3830.