|
Device | PIPELINE EMBOLIZATION DEVICE |
Generic Name | Intracranial aneurysm flow diverter |
Applicant | Micro Therapeutics, Inc. d/b/a ev3 NEUROVASCULAR 9775 Toledo Way Irvine, CA 92618 |
PMA Number | P100018 |
Supplement Number | S013 |
Date Received | 10/06/2014 |
Decision Date | 11/04/2014 |
Product Code |
OUT |
Advisory Committee |
Neurology |
Clinical Trials | NCT00777088
|
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE MODIFICATION OF SAFETY INFORMATION IN THE LABELING. |
Post-Approval Study | Show Report Schedule and Study Progress |