|
Device | STRATOS LV/LV-T CRT-P; COROX OTW (-S) BP & PTW-L BP LEADS |
Generic Name | Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P070008 |
Supplement Number | S016 |
Date Received | 05/28/2010 |
Decision Date | 07/30/2010 |
Product Code |
NKE |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS GERMANY GMBH, WIESBADEN, GERMANY AS AN ALTERNATE STERILIZATION FACILITY. 30-DAY NOTICES (135 DAY SUPPLEMENT WAS NOT REQUIRED) SUMMARY OF PMA ORIGINALS & SUPPLEMENTS APPROVEDORIGINALS: SUPPLEMENTS: SUMMARY OF PMA ORIGINALS UNDER REVIEWTOTAL UNDER REVIEW: TOTAL ACTIVE: TOTAL ON HOLD: NUMBER GREATER THAN 180 DAYS: SUMMARY OF PMA SUPPLEMENTS UNDER REVIEWTOTAL UNDER REVIEW: TOTAL ACTIVE: TOTAL ON HOLD: NUMBER GREATER THAN 180 DAYS: SUMMARY OF ALL PMA SUBMISSIONS RECEIVEDORIGINALS: SUPPLEMENTS: SUMMARY OF PMA SUPPLEMENT PMA APPROVAL/DENIAL DECISION TIMESNUMBER OF APPROVALS: NUMBER OF DENIALS: AVERAGE DAYS FR RECEIPT TO DECISION (TOTAL TIME): FDA TIME: DAYS MFR TIME: DAYS |