MEDTRONIC SELECTSECURE LEAD MODEL 3830
FDA premarket approval P030036/S004 · decided 2011-03-30
Approval details
- PMA number
- P030036
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC SELECTSECURE LEAD MODEL 3830
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2007-12-31
- Decision date
- 2011-03-30
- Days to decision
- 1185 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR IMPROVEMENTS TO THE CHEMISTRY, MANUFACTURING , AND CONTROLS (CMC) AND ELUTION METHODS AND SPECIFICATIONS FOR THE DRUG COATING ON SELECTSECURE MODEL 3830 LEADS.
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