PMA P080006S191
- Device
- MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD
- Applicant
- Medtronic, Inc.
- PMA number
- P080006
- Supplement
- S191
- Product code
- OJX
- Decision date
- 2025-05-14
- Classification
- Cardiovascular
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Approval order statement
- approval to allow a supplier site change for the wire coil component of the Ability and Performa leads
Current openFDA PMA Record#
- Device
- MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD
- Applicant
- Medtronic, Inc.
- PMA number
- P080006
- Supplement
- S191
- Product code
- OJX
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Decision date
- 2025-05-14
- Decision code
- OK30
- Date received
- 2025-04-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval to allow a supplier site change for the wire coil component of the Ability and Performa leads