- Device
- Attain Performa Lead, Attain Stability Quad MRI Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P080006
- Supplement
- S167
- Product code
- OJX
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Decision date
- 2021-12-17
- Decision code
- OK30
- Date received
- 2021-12-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the Pull Test Monitoring parameters used to monitor special manufacturing process in leads manufacturing.