|
Device | RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY CATHETER |
Generic Name | System, pacing, temporary, acute, internal atrial defibrillation |
Applicant | St. Jude Medical 14901 DEVEAU PLACE MINNEAPOLIS, MN 55345-2126 |
PMA Number | P020052 |
Supplement Number | S006 |
Date Received | 05/27/2010 |
Decision Date | 06/25/2010 |
Withdrawal Date
|
04/17/2015 |
Product Code |
MTE |
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 FOR MODIFICATIONS TO THE INSTRUCTIONS FOR USE. |