|
Device | CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIK LOAD |
Generic Name | Transcatheter septal occluder |
Applicant | NMT MEDICAL, INC. 27 WORMWOOD ST. BOSTON, MA 02210 |
PMA Number | P000049 |
Supplement Number | S015 |
Date Received | 08/13/2004 |
Decision Date | 09/13/2004 |
Product Code |
MLV |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO MODIFY THE PATIENT INFORMATION CARD TO INCLUDE A REVISED MRI COMPATIBILITY STATEMENT THAT SPECIFIES THAT THE COMPATIBILITY TESTING WAS PERFORMED WITH A 1.5 TESLA MAGNETIC FIELD. |