|
Device | TELIGEN HE DR/VR /CONFIENT |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960040 |
Supplement Number | S233 |
Date Received | 08/23/2010 |
Decision Date | 09/22/2010 |
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 |
Approval Order Statement CHANGE TO THE SHELF-LIFE EXPIRATION OF POLYURETHANE TUBING FROM 36 MONTHS TO ¿INDEFINITE¿. |