PMA P080006S124
- Device
- Attain Ability Lead / Attain Performa Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P080006
- Supplement
- S124
- Product code
- OJX
- Decision date
- 2018-06-27
- Classification
- Drug Eluting Permanent Left Ventricular (lv) Pacemaker Electrode
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Approval order statement
- Add a new alternate supplier for the Attain Performa coils.
Current openFDA PMA Record#
- Device
- Attain Ability Lead / Attain Performa Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P080006
- Supplement
- S124
- Product code
- OJX
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Decision date
- 2018-06-27
- Decision code
- OK30
- Date received
- 2018-06-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a new alternate supplier for the Attain Performa coils.