PMA P080006S171
- Device
- Attain Performa Lead, Attain Stability Quad MRI Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P080006
- Supplement
- S171
- Product code
- OJX
- Decision date
- 2022-05-03
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Approval order statement
- Change the heat shrinking manufacturing process for the indicator band component.
Current openFDA PMA Record#
- Device
- Attain Performa Lead, Attain Stability Quad MRI Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P080006
- Supplement
- S171
- Product code
- OJX
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Decision date
- 2022-05-03
- Decision code
- OK30
- Date received
- 2022-04-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change the heat shrinking manufacturing process for the indicator band component.