MEDTRONIC(R) CAPSURE(R) NOVUS STEROID ELUTING, BIPOLAR, TRANSVENOUS PACING LEAD MODELS 5054 AND 5554
FDA premarket approval P850089/S045 · decided 2001-01-08
Approval details
- PMA number
- P850089
- Supplement
- S045
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MEDTRONIC(R) CAPSURE(R) NOVUS STEROID ELUTING, BIPOLAR, TRANSVENOUS PACING LEAD MODELS 5054 AND 5554
- Generic name
- permanent pacemaker Electrode
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2000-12-07
- Decision date
- 2001-01-08
- Days to decision
- 32 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL TO DISTRIBUTE THE MEDTRONIC(R) CAPSURE(R) Z NOVUS MODELS 5054 AND 5554 PACING LEADS UNDER A NEW TRADE NAME. THE DEVICES WILL BE MARKETED UNDER THE TRADE NAME VITATRON IMPLUSE II MODELS IHP 09B AND IHP 09JB AND ARE INDICATED FOR PROVIDING PERMANENT PACING AND SENSING OF THE VENTRICLE (MODEL IHP 09B) AND ATRIUM (MODEL IHP 09JB) WHEN USED WITH A COMPATIBLE PULSE GENERATOR.
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