PMA P140004S016

Device
Superion Indirect Decompression System
Applicant
Boston Scientific Neuromodulation
PMA number
P140004
Supplement
S016
Product code
NQO
Decision date
2019-12-02
Generic name
Prosthesis, spinous process spacer/plate
Approval order statement
Approval for modifications made to the packaging of the implant.

Current openFDA PMA Record#

Device
Superion Indirect Decompression System
Applicant
Boston Scientific Neuromodulation
PMA number
P140004
Supplement
S016
Product code
NQO
Generic name
Prosthesis, spinous process spacer/plate
Decision date
2019-12-02
Decision code
APPR
Date received
2019-10-08
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for modifications made to the packaging of the implant.