PMA P140004S008

Device: Superion Indirect Decompression System
Applicant: Boston Scientific Neuromodulation
PMA number: P140004
Supplement: S008
Product code: NQO
Decision date: 2017-06-07
Classification: Prosthesis, Spinous Process Spacer/plate
Generic name: Prosthesis, spinous process spacer/plate
Approval order statement: Approval for a manufacturing site located at Turner Medical, Inc., 130 Durham Drive, Athens, Alabama for the production of the Superion InterSpinous Decompression System.

Current openFDA PMA Record#

Device: Superion Indirect Decompression System
Applicant: Boston Scientific Neuromodulation
PMA number: P140004
Supplement: S008
Product code: NQO
Generic name: Prosthesis, spinous process spacer/plate
Decision date: 2017-06-07
Decision code: APPR
Date received: 2017-02-21
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at Turner Medical, Inc., 130 Durham Drive, Athens, Alabama for the production of the Superion InterSpinous Decompression System.