SSCP
The Summary of Safety and Clinical Performance (SSCP) for Brainlab Class III medical devices is intended to provide direct information to the intended user on the safety and clinical performance of the medical device. The SSCP provides a summary of the clinical evaluation, information on indication and contraindications as well as warnings and risks related to the device. Furthermore, it contains information on the post-market surveillance and post-market clinical follow-up and it is updated annually.
The SSCP is not intended to give general advice on the diagnosis or treatment of particular medical conditions, nor to replace the Instructions For Use as the main document to ensure the safe use of the device, nor to replace any other mandatory documents.
Downloads
Disposable Stylet
Summary of Safety and Clinical Performance-Disposable Stylet BG
Summary of Safety and Clinical Performance-Disposable Stylet CS
Summary of Safety and Clinical Performance-Disposable Stylet DA
Summary of Safety and Clinical Performance-Disposable Stylet DE
Summary of Safety and Clinical Performance-Disposable Stylet EL
Summary of Safety and Clinical Performance-Disposable Stylet EN
Summary of Safety and Clinical Performance-Disposable Stylet EP
Summary of Safety and Clinical Performance-Disposable Stylet ES
Summary of Safety and Clinical Performance-Disposable Stylet ET
Summary of Safety and Clinical Performance-Disposable Stylet FI
Summary of Safety and Clinical Performance-Disposable Stylet FR
Summary of Safety and Clinical Performance-Disposable Stylet HR
Summary of Safety and Clinical Performance-Disposable Stylet HU
Summary of Safety and Clinical Performance-Disposable Stylet IT
Summary of Safety and Clinical Performance-Disposable Stylet LT
Summary of Safety and Clinical Performance-Disposable Stylet LV
Summary of Safety and Clinical Performance-Disposable Stylet NL
Summary of Safety and Clinical Performance-Disposable Stylet PL
Summary of Safety and Clinical Performance-Disposable Stylet RO
Summary of Safety and Clinical Performance-Disposable Stylet SK
Summary of Safety and Clinical Performance-Disposable Stylet SL
Summary of Safety and Clinical Performance-Disposable Stylet SV
EM Disposable Stylet
Summary of Safety and Clinical Performance-EM Disposable Stylet BG
Summary of Safety and Clinical Performance-EM Disposable Stylet CS
Summary of Safety and Clinical Performance-EM Disposable Stylet DA
Summary of Safety and Clinical Performance-EM Disposable Stylet DE
Summary of Safety and Clinical Performance-EM Disposable Stylet EL
Summary of Safety and Clinical Performance-EM Disposable Stylet EN
Summary of Safety and Clinical Performance-EM EM Disposable Stylet EP
Summary of Safety and Clinical Performance-EM Disposable Stylet ES
Summary of Safety and Clinical Performance-EM Disposable Stylet ET
Summary of Safety and Clinical Performance-EM Disposable Stylet FI
Summary of Safety and Clinical Performance-EM Disposable Stylet FR
Summary of Safety and Clinical Performance-EM Disposable Stylet HR
Summary of Safety and Clinical Performance-EM Disposable Stylet HU
Summary of Safety and Clinical Performance-EM Disposable Stylet IT
Summary of Safety and Clinical Performance-EM Disposable Stylet LT
Summary of Safety and Clinical Performance-EM Disposable Stylet LV
Summary of Safety and Clinical Performance-EM Disposable Stylet NL
Summary of Safety and Clinical Performance-EM Disposable Stylet PL
Summary of Safety and Clinical Performance-EM Disposable Stylet RO
Summary of Safety and Clinical Performance-EM Disposable Stylet SK
Summary of Safety and Clinical Performance-EM Disposable Stylet SL
Summary of Safety and Clinical Performance-EM Disposable Stylet SV