|
Device | CONTAK RENEWAL RF HEART FAILURE PULSE GENERATORS |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | P010012 |
Supplement Number | S171 |
Date Received | 01/24/2008 |
Decision Date | 02/25/2008 |
Product Code |
LWP |
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 USE OF THE EXISTING INNER LEAD BONDING (ILB) MACHINES TO PROCESS THE INSIGNIA MIXED MODE TAB AND THE RENEWAL RF ANALOG TAB. |