|
Device | LINOX SD AND LINOX S FAMILY OF ICD PACING LEADS |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P980023 |
Supplement Number | S040 |
Date Received | 04/13/2010 |
Decision Date | 05/13/2010 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE IN PACKAGING TO THE INNER AND OUTER BAGS OF THE STERILIZED STYLET ACCESSORIES. |