PMA P080006S161
- Device
- Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P080006
- Supplement
- S161
- Product code
- OJX
- Decision date
- 2021-06-23
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Approval order statement
- Changes to the cleaning process of stylet components manufactured at the supplier.
Current openFDA PMA Record#
- Device
- Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P080006
- Supplement
- S161
- Product code
- OJX
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Decision date
- 2021-06-23
- Decision code
- OK30
- Date received
- 2021-06-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the cleaning process of stylet components manufactured at the supplier.