PMA P140004S033

Device: Superion Indirect Decompression System
Applicant: Boston Scientific Neuromodulation
PMA number: P140004
Supplement: S033
Product code: NQO
Decision date: 2024-08-22
Classification: Orthopedic
Generic name: Prosthesis, spinous process spacer/plate
Approval order statement: approval to manufacture the Superion IDS Instrument kits (Vertiflex Instrument Platform Kit (VIP Kit) and Single Use Instruments Kit (SUI Kit)) at the following alternate manufacturing site: AUSA Medical Devices (Adroit USA, Inc.)

Current openFDA PMA Record#

Device: Superion Indirect Decompression System
Applicant: Boston Scientific Neuromodulation
PMA number: P140004
Supplement: S033
Product code: NQO
Generic name: Prosthesis, spinous process spacer/plate
Decision date: 2024-08-22
Decision code: APPR
Date received: 2024-06-06
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval to manufacture the Superion IDS Instrument kits (Vertiflex Instrument Platform Kit (VIP Kit) and Single Use Instruments Kit (SUI Kit)) at the following alternate manufacturing site: AUSA Medical Devices (Adroit USA, Inc.)