- Device
- Attain Ability Lead, Attain Performa Lead (4398,4598), Attain Performa Lead (4298), Attain Stability Quad MRI Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P080006
- Supplement
- S192
- Product code
- OJX
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Decision date
- 2026-04-15
- Decision code
- OK30
- Date received
- 2026-03-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to reduce the bioburden monitoring frequency from bi-weekly to monthly