PMA P080006S186

Device: Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead
Applicant: Medtronic, Inc.
PMA number: P080006
Supplement: S186
Product code: OJX
Decision date: 2024-10-17
Classification: Cardiovascular
Generic name: Drug eluting permanent left ventricular (lv) pacemaker electrode
Approval order statement: to update a silicone raw material incoming inspection procedure, location, and frequency

Current openFDA PMA Record#

Device: Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead
Applicant: Medtronic, Inc.
PMA number: P080006
Supplement: S186
Product code: OJX
Generic name: Drug eluting permanent left ventricular (lv) pacemaker electrode
Decision date: 2024-10-17
Decision code: OK30
Date received: 2024-10-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to update a silicone raw material incoming inspection procedure, location, and frequency