|
Device | MERIDIAN, MODELS 976,1176, 1276 |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P940031 |
Supplement Number | S054 |
Date Received | 05/02/2006 |
Decision Date | 09/15/2006 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF THE AUTOMATION OF A QUERY REVIEW PROCESS AND THE ADDITION OF AN AUTOMATED RELEASE AND SIGNOFF STEP. |