SELECTSECURE LEAD
FDA premarket approval P030036/S051 · decided 2012-12-19
Approval details
- PMA number
- P030036
- Supplement
- S051
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SELECTSECURE LEAD
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-10-26
- Decision date
- 2012-12-19
- Days to decision
- 54 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR CHANGE IN SILICONE TUBING MATERIAL USED IN THE MANUFACTURE OF VARIOUS CARDIAC LEADS AS A RESULT OF DISCONTINUATION OF THE CURRENT MATERIAL BY AN OUTSIDE SUPPLIER.
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