PMA P840001S498

Device: Master Restore, Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, Vectris Spinal C
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S498
Product code: LGW
Decision date: 2021-09-01
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement: Approval for 1) equipment updates in the CEA 2-3 Silicone Molding area (e.g., six additional ovens), updated option for use of temperature recorder (Vaisala Monitoring System Model VL-1700-54T), updated oven mode for the new ovens to use Manual Mode, removal of monitor lot for all ovens, removal of setup lot of new ovens, addition of a new and smaller basket for oven use, and addition of a new toolmaker scope (Nikon MM-40), 2) an update to the applicable work instructions (WI); and 3) the oven operation of allowing the new ovens to be opened during the middle of a run to add or remove lots from the oven and FACTORYworks (FW) updates to support the changes.

Current openFDA PMA Record#

Device: Master Restore, Itrel, Synergy, Intellis and Vanta Spinal Cord Stimulation Systems and Pisces, Specify, Vectris Spinal C
Applicant: Medtronic Neuromodulation
PMA number: P840001
Supplement: S498
Product code: LGW
Generic name: Stimulator, spinal-cord, totally implanted for pain relief
Decision date: 2021-09-01
Decision code: OK30
Date received: 2021-08-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for 1) equipment updates in the CEA 2-3 Silicone Molding area (e.g., six additional ovens), updated option for use of temperature recorder (Vaisala Monitoring System Model VL-1700-54T), updated oven mode for the new ovens to use Manual Mode, removal of monitor lot for all ovens, removal of setup lot of new ovens, addition of a new and smaller basket for oven use, and addition of a new toolmaker scope (Nikon MM-40), 2) an update to the applicable work instructions (WI); and 3) the oven operation of allowing the new ovens to be opened during the middle of a run to add or remove lots from the oven and FACTORYworks (FW) updates to support the changes.