|
Device | PRIZM FAMILY |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960040 |
Supplement Number | S075 |
Date Received | 08/15/2005 |
Decision Date | 11/24/2005 |
Product Codes |
KRG 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 |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE USE OF FOUR NEW INNER LEAD BONDING (ILB) MACHINES ON THE TAPE AUTOMATED BONDING (TAB) MANUFACTURING LINE FOR PULSE GENERATORS. |