PMA P180031S004

Device: Neuroform Atlas® Stent System
Applicant: Stryker Neurovascular
PMA number: P180031
Supplement: S004
Product code: QCA
Decision date: 2022-02-07
Generic name: Intracranial coil-assist stent
Approval order statement: Three changes to the non-patient contacting introducer sheath component of the Neuroform Atlas Stent System: 1) sheath manufacturing to be outsourced to an external supplier; 2) change from a three- to two-step manufacturing process; and 3) tip length specification simplification and change of the nominal length.

Current openFDA PMA Record#

Device: Neuroform Atlas® Stent System
Applicant: Stryker Neurovascular
PMA number: P180031
Supplement: S004
Product code: QCA
Generic name: Intracranial coil-assist stent
Decision date: 2022-02-07
Decision code: OK30
Date received: 2022-01-12
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Three changes to the non-patient contacting introducer sheath component of the Neuroform Atlas Stent System: 1) sheath manufacturing to be outsourced to an external supplier; 2) change from a three- to two-step manufacturing process; and 3) tip length specification simplification and change of the nominal length.