PMA P030004S021

Device: Apollo Onyx Delivery Microcatheter
Applicant: Ev3 Neurovascular
PMA number: P030004
Supplement: S021
Product code: MFE
Decision date: 2019-12-10
Generic name: Agent, injectable, embolic
Approval order statement: Approval for a manufacturing site located at Medtronic Distribution Center, 4340 Swinnea Road, Memphis, Tennessee 38118, for the repackaging of the Apollo Onyx Delivery Microcatheter and Pipeline Flex Embolization Device.

Current openFDA PMA Record#

Device: Apollo Onyx Delivery Microcatheter
Applicant: Ev3 Neurovascular
PMA number: P030004
Supplement: S021
Product code: MFE
Generic name: Agent, injectable, embolic
Decision date: 2019-12-10
Decision code: APPR
Date received: 2019-08-21
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at Medtronic Distribution Center, 4340 Swinnea Road, Memphis, Tennessee 38118, for the repackaging of the Apollo Onyx Delivery Microcatheter and Pipeline Flex Embolization Device.