Pipeline Flex Embolization Device
FDA premarket approval P100018/S022 · decided 2019-12-10
Approval details
- PMA number
- P100018
- Supplement
- S022
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Pipeline Flex Embolization Device
- Generic name
- Intracranial aneurysm flow diverter
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Date received
- 2019-08-21
- Decision date
- 2019-12-10
- Days to decision
- 111 days
- Decision code
- APPR
- Product code
- OUT
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Irvine, CA
- 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 Micro Catheter and Pipeline Flex Embolization Device.
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