PMA P860004S446

Device: SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters
Applicant: Medtronic, Inc.
PMA number: P860004
Supplement: S446
Product code: LKK
Decision date: 2025-07-17
Classification: General Hospital
Generic name: Pump, infusion, implanted, programmable
Approval order statement: reduced bacterial endotoxin testing frequency and sample size for the Connector Plug Accessory Kit (model B31060), the Bolero Interstim Revision Kit (model 3560031), the Tunneling Tools and Catheter Passers, the Torque Wrenches and Injex families manufactured at Juncos, Puerto Rico facility

Current openFDA PMA Record#

Device: SynchroMed™ Infusion System, Ascenda™ Intrathecal Catheters
Applicant: Medtronic, Inc.
PMA number: P860004
Supplement: S446
Product code: LKK
Generic name: Pump, infusion, implanted, programmable
Decision date: 2025-07-17
Decision code: OK30
Date received: 2025-06-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: reduced bacterial endotoxin testing frequency and sample size for the Connector Plug Accessory Kit (model B31060), the Bolero Interstim Revision Kit (model 3560031), the Tunneling Tools and Catheter Passers, the Torque Wrenches and Injex families manufactured at Juncos, Puerto Rico facility