Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
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 |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE THE SOFTWARE USED TO GENERATE PRINTED WORK ORDERS. |
|
|