FDA.reportPublic FDA data

PMA P010015S589

Device
Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1TR02); Serena Quadripolar
Applicant
Medtronic, Inc.
PMA number
P010015
Supplement
S589
Product code
LWP
Decision date
2026-07-31
Classification
Cardiovascular
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Approval order statement
to implement additional sub-tier raw material suppliers and other minor process changes for components used in the hybrid subassemblies of Medtronic cardiac rhythm management (CRM) devices.

Current openFDA PMA Record#

Device
Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1TR02); Serena Quadripolar
Applicant
Medtronic, Inc.
PMA number
P010015
Supplement
S589
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
Decision date
2026-07-31
Decision code
OK30
Date received
2026-07-07
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
to implement additional sub-tier raw material suppliers and other minor process changes for components used in the hybrid subassemblies of Medtronic cardiac rhythm management (CRM) devices.