Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
Basic Information
- Device Name
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)
- Trade Name
- STRATOS LV/LV-T CRT-P; COROX OTW (-S) BP & PTW-L BP LEADS
- PMA Number
- P070008
- Supplement Number
- S016
- Device Class
- FDA Class 3
- Product Code
- NKE
- Generic Name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- July 30, 2010
- Date Received
- May 28, 2010
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee 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
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NKE | Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) | FDA class 3 | Unknown |