PMA P030017S317
- Device
- Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Precision Spectra WaveWriter
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S317
- Product code
- LGW
- Decision date
- 2018-08-02
- Classification
- Stimulator, Spinal-cord, Totally Implanted For Pain Relief
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Approval order statement
- Addition of Guidant Puerto Rico B.V. as an alternate qualified manufacturing site for the laser ablation of multi-lumen tubes used in the assembly of the following leads for the Precision®, Precision Spectra, Precision NoviTM, Precision Montage, Precision MontageTM MRI and Precision Spectra WaveWriter Spinal Cord Stimulator (SCS) Systems: Linear Leads, Linear ST Leads, Linear 3-4 Leads, Linear 3-6 Leads, Lead Extensions, M8 & S8 Adapters, Artisan Surgical Leads, Artisan MRI Surgical Leads, CovcrEdge Surgical Leads, CoverEdge X Surgical Leads, Infinion and lnfinion CX 16 Contact Leads.
Current openFDA PMA Record#
- Device
- Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Precision Spectra WaveWriter
- Applicant
- Boston Scientific Corp
- PMA number
- P030017
- Supplement
- S317
- Product code
- LGW
- Generic name
- Stimulator, spinal-cord, totally implanted for pain relief
- Decision date
- 2018-08-02
- Decision code
- OK30
- Date received
- 2018-07-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of Guidant Puerto Rico B.V. as an alternate qualified manufacturing site for the laser ablation of multi-lumen tubes used in the assembly of the following leads for the Precision®, Precision Spectra, Precision NoviTM, Precision Montage, Precision MontageTM MRI and Precision Spectra WaveWriter Spinal Cord Stimulator (SCS) Systems: Linear Leads, Linear ST Leads, Linear 3-4 Leads, Linear 3-6 Leads, Lead Extensions, M8 & S8 Adapters, Artisan Surgical Leads, Artisan MRI Surgical Leads, CovcrEdge Surgical Leads, CoverEdge X Surgical Leads, Infinion and lnfinion CX 16 Contact Leads.