PMA P080006S188

Device: Attain Performa Lead, Attain Stability Quad MRI Lead
Applicant: Medtronic, Inc.
PMA number: P080006
Supplement: S188
Product code: OJX
Decision date: 2025-01-22
Classification: Cardiovascular
Generic name: Drug eluting permanent left ventricular (lv) pacemaker electrode
Approval order statement: modification of high-potential electrical testing to allow re-testing of failed leads with separate equipment

Current openFDA PMA Record#

Device: Attain Performa Lead, Attain Stability Quad MRI Lead
Applicant: Medtronic, Inc.
PMA number: P080006
Supplement: S188
Product code: OJX
Generic name: Drug eluting permanent left ventricular (lv) pacemaker electrode
Decision date: 2025-01-22
Decision code: OK30
Date received: 2025-01-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: modification of high-potential electrical testing to allow re-testing of failed leads with separate equipment