CAPSURE(R) AND CAPSURE(R) SP SILICONE PACING LEADS
FDA premarket approval P850089/S036 · decided 1997-02-04
Approval details
- PMA number
- P850089
- Supplement
- S036
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CAPSURE(R) AND CAPSURE(R) SP SILICONE PACING LEADS
- Generic name
- permanent pacemaker Electrode
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 1996-11-20
- Decision date
- 1997-02-04
- Days to decision
- 76 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR DISTRIBUTION BY VIATRON, INC. OF THE MODELS CAPSURE(R) Z, 5033, 5934, 5534 AND CAPSUREFIX(R) 4068 UNDER A NEW TRADE NAME. THE DEVICES WILL BE MARKETED UNDER THE TRADE NAMES VITATRON(R) IMPULSE(TM) IMG 49, IMPULSE(TM) IMG 49B, IMPULSE(TM) IMG 49JB, AND PIROUET(TM)+IMU 49B. AND ARE INDICATED FOR CHRONIC PACING AND SENSING OF THE ATRIUM AND/OR VENTRICLE.
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