SELECTSECURE LEAD
FDA premarket approval P030036/S058 · decided 2013-07-23
Approval details
- PMA number
- P030036
- Supplement
- S058
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SELECTSECURE LEAD
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2013-05-17
- Decision date
- 2013-07-23
- Days to decision
- 67 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR AN INCREASE IN THE STORAGE SHELF LIFE OF THE TYVEK LID COMPONENT, WHICH INCLUDES THE ADHESIVE COATING, USED IN THE MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT PRODUCTS FROM 18 MONTHS TO 48 MONTHS.
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