510(k) K060681

MEDTRONIC PS MEDICAL STRATA TYPE VALUE by Medtronic Neurosurgery — Product Code JXG

K060681 is an FDA 510(k) premarket notification submitted by Medtronic Neurosurgery for the device "MEDTRONIC PS MEDICAL STRATA TYPE VALUE". The FDA issued a decision of Substantially Equivalent on September 15, 2006. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Medtronic Neurosurgery has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2006
Date Received
March 15, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shunt, Central Nervous System And Components
Device Class
Class II
Regulation Number
882.5550
Review Panel
NE
Submission Type