PMA P010015S579
- Device
- Attain OTW LV Lead; Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Qua
- Applicant
- Medtronic, Inc.
- PMA number
- P010015
- Supplement
- S579
- Product code
- LWP
- Decision date
- 2026-02-10
- Classification
- Cardiovascular
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- a new vapor degreasing solvent
Current openFDA PMA Record#
- Device
- Attain OTW LV Lead; Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Qua
- Applicant
- Medtronic, Inc.
- PMA number
- P010015
- Supplement
- S579
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2026-02-10
- Decision code
- OK30
- Date received
- 2026-01-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a new vapor degreasing solvent