PMA P010015S481
- Device
- Attain Bipolar OTW Lead, Attain OTW LV Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P010015
- Supplement
- S481
- Product code
- LWP
- Decision date
- 2021-08-17
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Minor modifications, including new ovens and a new toolmaker's scope at Medtronic Rice Creek.
Current openFDA PMA Record#
- Device
- Attain Bipolar OTW Lead, Attain OTW LV Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P010015
- Supplement
- S481
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2021-08-17
- Decision code
- OK30
- Date received
- 2021-08-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Minor modifications, including new ovens and a new toolmaker's scope at Medtronic Rice Creek.