PMA P860004S397
- Device
- Master SynchroMed™ II Infusion System
- Applicant
- Medtronic, Inc.
- PMA number
- P860004
- Supplement
- S397
- Product code
- LKK
- Decision date
- 2022-09-16
- Generic name
- Pump, infusion, implanted, programmable
- Approval order statement
- Approval for labeling updates for the Targeted Drug Delivery (TDD) Therapy labeling.
Current openFDA PMA Record#
- Device
- Master SynchroMed™ II Infusion System
- Applicant
- Medtronic, Inc.
- PMA number
- P860004
- Supplement
- S397
- Product code
- LKK
- Generic name
- Pump, infusion, implanted, programmable
- Decision date
- 2022-09-16
- Decision code
- APPR
- Date received
- 2022-08-19
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for labeling updates for the Targeted Drug Delivery (TDD) Therapy labeling.