MEDTRONIC MODEL 6940 STERIOC ELUTING BIPOLAR IMPALNTABLE SCREW-IN VENTRICULAR/ATRIAL TRANSVENOUS LEAD
FDA premarket approval P980016/S004 · decided 1999-03-05
Approval details
- PMA number
- P980016
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MEDTRONIC MODEL 6940 STERIOC ELUTING BIPOLAR IMPALNTABLE SCREW-IN VENTRICULAR/ATRIAL TRANSVENOUS LEAD
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1999-02-08
- Decision date
- 1999-03-05
- Days to decision
- 25 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for use of the Model 6940 CapSureFix Ventricular/Atrial Transvenous Lead. The device, as modified will be marketed under the trade name Model 6940 CapSureFix Lead and is intended for single long-term use in the right ventricle or right atrium for pacing and sensing.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.