PMA P840001S049
- Device
- ITREL SPINAL CORD STIMULATION (SCS) SYSTEM
- Applicant
- Medtronic Neuromodulation
- PMA number
- P840001
- Supplement
- S049
- Product code
- LGW
- Decision date
- 2000-12-13
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- A MANUFACTURING PROCESS CHANGE FROM A RESISTANCE WELD TO A LASER WELD.
Current openFDA PMA Record#
- Device
- ITREL SPINAL CORD STIMULATION (SCS) SYSTEM
- Applicant
- Medtronic Neuromodulation
- PMA number
- P840001
- Supplement
- S049
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2000-12-13
- Decision code
- OK30
- Date received
- 2000-11-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- A MANUFACTURING PROCESS CHANGE FROM A RESISTANCE WELD TO A LASER WELD.