MEDTRONIC(R) CAPSUREFIX MODEL 4067/4568/5067/5068/5568 PACING LEAD
FDA premarket approval P930039/S002 · decided 1997-01-02
Approval details
- PMA number
- P930039
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC(R) CAPSUREFIX MODEL 4067/4568/5067/5068/5568 PACING LEAD
- Generic name
- permanent pacemaker Electrode
- Applicant
- Medtronic, Inc.
- Date received
- 1996-06-24
- Decision date
- 1997-01-02
- Days to decision
- 192 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE ADDITION OF MODEL 4067, 4568, 5067, 5068 AND 5568 TO THE CAPSUREFIX(R) LINE. THESE LEAD MODELS WILL ALSO BE DISTRIBUTED BY VIATRON, INC., UNDER THE TRADENAME "PIROUT" (MODELS IMU49, IMU49JB, IMX49, IMX49B AND IMU49JB).
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