PIPELINE EMBOLIZATION DEVICE
FDA premarket approval P100018/S008 · decided 2013-10-22
Approval details
- PMA number
- P100018
- Supplement
- S008
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PIPELINE EMBOLIZATION DEVICE
- Generic name
- Intracranial aneurysm flow diverter
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Date received
- 2013-07-22
- Decision date
- 2013-10-22
- Days to decision
- 92 days
- Decision code
- APPR
- Product code
- OUT
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A DESIGN CHANGE FOR THE SHORTER PIPELINE¿ EMBOLIZATIONDEVICES (PED), MODEL NUMBERS FA-77XXX-XX, WITH LENGTHS BETWEEN 10MM AND 20MM. THIS DESIGN CHANGE INVOLVES REPLACING THE DELIVERY CORE WIRE CURRENTLY AVAILABLE ON THESE SHORTER PED LENGTHS (RM-00013-XX) WITH THE DELIVERY CORE WIRE CURRENTLY AVAILABLE ON THE LONGER PEDLENGTHS (RM-00089-XX), MODEL NUMBERS FA-71XXX-XX, BETWEEN 25MM AND 35MM.
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