CAPSUREFIX MRI SURE AND SCAN LEAD
FDA premarket approval P090013/S164 · decided 2016-03-18
Approval details
- PMA number
- P090013
- Supplement
- S164
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CAPSUREFIX MRI SURE AND SCAN LEAD
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2014-12-08
- Decision date
- 2016-03-18
- Days to decision
- 466 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for a design change to the lead helix electrode and a manufacturing site change and the related update to analytical methods and tightened specifications proposed for drug related elements of the medical devices.
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