PIPELINE EMBOLIZATION DEVICES,PIPELINE FLEX EMBOLIZATION DEVICE
FDA premarket approval P100018/S011 · decided 2015-01-26
Approval details
- PMA number
- P100018
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PIPELINE EMBOLIZATION DEVICES,PIPELINE FLEX EMBOLIZATION DEVICE
- Generic name
- Intracranial aneurysm flow diverter
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Date received
- 2014-06-26
- Decision date
- 2015-01-26
- Days to decision
- 214 days
- Decision code
- APPR
- Product code
- OUT
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR DESIGN CHANGES TO THE DELIVERY SYSTEM OF THE PIPELINE¿ EMBOLIZATION SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME, PIPELINE¿ FLEX EMBOLIZATION DEVICE (PFED), AND REMAINS INDICATED FOR THE ENDOVASCULAR TREATMENT OF ADULTS (22 YEARS OF AGE OR OLDER) WITH LARGE OR GIANT WIDE-NECKED INTRACRANIAL ANEURYSMS (IAS) IN THE INTERNAL CAROTID ARTERY FROM THE PETROUS TO THE SUPERIOR HYPOPHYSEAL SEGMENTS.
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