MODEL 6960 SWITCHABLE ECG PATIENT CABLE
FDA premarket approval P910077/S026 · decided 1999-01-20
Approval details
- PMA number
- P910077
- Supplement
- S026
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 6960 SWITCHABLE ECG PATIENT CABLE
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1998-12-21
- Decision date
- 1999-01-20
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approva for a switchable ECG cable that allows the clinician to display and record ECG signals from seven different vectors (leads) without moving the ECG electrodes that are attached to the patient. The device, as modified, will be marketed under the trade name Model 6960 Switchable ECG Cable and is indicated for use as an accessory to the Models 2950 and 2901 Programmer/Recorder/Monitors (PRMs).
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