PIPELINE EMBOLIZATION DEVICE
FDA premarket approval P100018 · decided 2011-04-06
Approval details
- PMA number
- P100018
- Trade name
- PIPELINE EMBOLIZATION DEVICE
- Generic name
- Intracranial aneurysm flow diverter
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Date received
- 2010-05-18
- Decision date
- 2011-04-06
- Days to decision
- 323 days
- Decision code
- APPR
- Product code
- OUT
- Advisory committee
- Neurology
- Expedited review
- Yes
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE PIPELINE EMBOLIZATION DEVICE. THIS DEVICE IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF ADULTS (AGE 22 AND ABOVE) WITH LARGE OR GIANT WIDE-NECKED INTRACRANIAL ANEURYSMS IN THE INTERNAL CAROTID ARTERY FROM THE PETROUS TO THE SUPERIOR HYPOPHYSEAL SEGMENTS.
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