PMA P840001S247
- Device
- SCS EXTENSIONS, SCS LEADS, SCS LEADS 1X8 FAMILY, SCS LEADS PISCES FAMILY, SCS LEADS SPECIFY FAMILY
- Applicant
- Medtronic Neuromodulation
- PMA number
- P840001
- Supplement
- S247
- Product code
- LGW
- Decision date
- 2013-10-03
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- UPDATES TO THE CURRENT FINAL PACKLABEL PRINTING EQUIPMENT CONTROLLER, WHICH IS USED DURING THE STERILE FINAL PACKAGE OPERATION ATMEDTRONIC PUERTO RICO OPERATIONS COMPANY (MPROC) IN VILLALBA, PUERTO RICO.
Current openFDA PMA Record#
- Device
- SCS EXTENSIONS, SCS LEADS, SCS LEADS 1X8 FAMILY, SCS LEADS PISCES FAMILY, SCS LEADS SPECIFY FAMILY
- Applicant
- Medtronic Neuromodulation
- PMA number
- P840001
- Supplement
- S247
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2013-10-03
- Decision code
- OK30
- Date received
- 2013-09-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- UPDATES TO THE CURRENT FINAL PACKLABEL PRINTING EQUIPMENT CONTROLLER, WHICH IS USED DURING THE STERILE FINAL PACKAGE OPERATION ATMEDTRONIC PUERTO RICO OPERATIONS COMPANY (MPROC) IN VILLALBA, PUERTO RICO.