|
Device | ISOLINE 2CR PACINGS LEADS |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P980049 |
Supplement Number | S049 |
Date Received | 06/16/2009 |
Decision Date | 07/15/2009 |
Product Code |
MRM |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | Yes |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE ADDITION OF TWO WARNINGS REGARDING THE USE OF STRAIGHT STYLETS DURING IMPLANT PROCEDURES WITH THE ISOLINE 2CR DEFIBRILLATION LEADS. |