PMA P080006S180
- Device
- Attain Performa Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P080006
- Supplement
- S180
- Product code
- OJX
- Decision date
- 2023-11-17
- Classification
- Cardiovascular
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Approval order statement
- to reduce the sample size and update the alert reasonable limits used to monitor the leads pull test
Current openFDA PMA Record#
- Device
- Attain Performa Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P080006
- Supplement
- S180
- Product code
- OJX
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Decision date
- 2023-11-17
- Decision code
- OK30
- Date received
- 2023-10-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to reduce the sample size and update the alert reasonable limits used to monitor the leads pull test