PMA P140004S026

Device: Superion™ Indirect Decompression System (IDS) Kit, Vertiflex Instrument Platform (VIP) Kit
Applicant: Boston Scientific Neuromodulation
PMA number: P140004
Supplement: S026
Product code: NQO
Decision date: 2021-10-07
Generic name: Prosthesis, spinous process spacer/plate
Approval order statement: Distribute the device incorporating the change as requested in this supplement. This change adds an additional supplier for the Superion Indirect Decompression System (IDS) instrument kits tray retainer lid. The following manufacturing facility is affected by the change; New supplier: Nelipak- Mervue, Galway, Ireland.

Current openFDA PMA Record#

Device: Superion™ Indirect Decompression System (IDS) Kit, Vertiflex Instrument Platform (VIP) Kit
Applicant: Boston Scientific Neuromodulation
PMA number: P140004
Supplement: S026
Product code: NQO
Generic name: Prosthesis, spinous process spacer/plate
Decision date: 2021-10-07
Decision code: OK30
Date received: 2021-09-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Distribute the device incorporating the change as requested in this supplement. This change adds an additional supplier for the Superion Indirect Decompression System (IDS) instrument kits tray retainer lid. The following manufacturing facility is affected by the change; New supplier: Nelipak- Mervue, Galway, Ireland.