MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568
FDA premarket approval P930039/S148 · decided 2016-08-24
Approval details
- PMA number
- P930039
- Supplement
- S148
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Medtronic, Inc.
- Date received
- 2016-03-01
- Decision date
- 2016-08-24
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for the expansion of MRI conditional labeling for the Amplia MRI and Compia MRI Systems to include 3T MRI.
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