PIPELINE EMBOLIZATION DEVICE
FDA premarket approval P100018/S003 · decided 2011-08-30
Approval details
- PMA number
- P100018
- Supplement
- S003
- Supplement type
- Special (Immediate Track)
- Trade name
- PIPELINE EMBOLIZATION DEVICE
- Generic name
- Intracranial aneurysm flow diverter
- Applicant
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
- Date received
- 2011-08-01
- Decision date
- 2011-08-30
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- OUT
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR ADDING A WARNING ABOUT ALLERGIES TO METALS USED IN THE DEVICE AND CLARIFYING YOUR INSTRUCTIONS FOR UESE.
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