|
Device | ZOOM LATITUDE PROGRAMMER |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910077 |
Supplement Number | S136 |
Date Received | 07/22/2013 |
Decision Date | 08/21/2013 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement ALTERNATE SUPPLIER FOR THE OFF-THE-SHELF FLASH MEMORY CHIP TO BE USED ON THEINPUT/OUTPUT (I/O) PRINTED CIRCUIT ASSEMBLY (PCA) OF THE DEVICE. |