|
Device | PIPLINE TM 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 | S006 |
Date Received | 03/12/2013 |
Decision Date | 04/02/2013 |
Product Code |
OUT |
Advisory Committee |
Neurology |
Clinical Trials | NCT00777088
|
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement CHANGE THE SOFTWARE USED TO GENERATE PRINTED WORK ORDERS. |
Post-Approval Study | Show Report Schedule and Study Progress |