Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• 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 Rd.; 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
• Predetermined Change Control Plan Authorized: 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