MEDTRONIC SELECTSECURE LEAD MODEL 3830
FDA premarket approval P030036/S002 · decided 2006-10-11
Approval details
- PMA number
- P030036
- Supplement
- S002
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MEDTRONIC SELECTSECURE LEAD MODEL 3830
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2006-09-07
- Decision date
- 2006-10-11
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A LABEL CHANGE TO THE TECHNICAL MANUAL FOR THE SELECTSECURE LEAD MODEL 3830.
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