PIPELINE EMBOLIZATION DEVICE
FDA premarket approval P100018/S004 · decided 2012-03-22
Approval details
- PMA number
- P100018
- Supplement
- S004
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PIPELINE EMBOLIZATION DEVICE
- Generic name
- Intracranial aneurysm flow diverter
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Date received
- 2011-09-19
- Decision date
- 2012-03-22
- Days to decision
- 185 days
- Decision code
- APPR
- Product code
- OUT
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT EV3 NEUROVASCULAR, IRVINE, CALIFORNIA AS AN ADDITIONAL MANUFACTURING SITE FOR THE DEVICE.
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