SynchroMed Infusion System, Ascenda Intrathecal Catheters
Medtronic, Inc. · Pump, infusion, implanted, programmable · General Hospital
Open FDA's page for this record- PMA number
- P860004
- Supplement number
- S465
- Applicant
- Medtronic, Inc.
- Street 1
- 7000 Central Ave., NE
- City
- Minneapolis
- State
- MN
- Zip
- 55432
- Generic name
- Pump, infusion, implanted, programmable
- Trade name
- SynchroMed Infusion System, Ascenda Intrathecal Catheters
- Product code
- LKK
- Advisory committee
- HO
- Advisory committee description
- General Hospital
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited review flag
- N
- Date received
- 2026-09-30
- Decision date
- 2026-10-30
- Decision code
- OK30
- Ao statement
approval for the following three changes: 1) Adding a new surface mount technology (SMT) production line.2) Revision of the SMT manufacturing process sequence to perform automated optical inspection immediately following each SMT assembly stage.3) Addition of an equivalent solder paste inspection system and addition of a qualified de-paneling machine for PCBA production
- Harmonized identifiers (openFDA)
- Device name
- Pump, Infusion, Implanted, Programmable
- Medical specialty description
- Unknown
- Device class
- 3
- Registration number
- 3009183442, 3003174284, 3018094310, 2523676, 3003120897, 2246552, 1526611, 2135338, 1422634, 3004593495, 3004209178, 2183319, 1722746, 3030198397, 2182207, 2032227, 3007829657, 3015537318, 2124215
- FEI number
- 3009183442, 3003174284, 3018094310, 2523676, 1000514656, 3003120897, 2246552, 1526611, 3004593495, 3004369318, 3005700659, 3003166194, 2183319, 3030198397, 2182207, 3007829657, 3015537318, 1000306216, 2124215