SELECTSURE LEAD
FDA premarket approval P030036/S067 · decided 2013-12-16
Approval details
- PMA number
- P030036
- Supplement
- S067
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SELECTSURE LEAD
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2013-11-22
- Decision date
- 2013-12-16
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- TRANSFER OF INCOMING INSPECTION TO A NEW SITE FOR A NUMBER OF COMPONENTS USED IN THE MANUFACTURE OF MEDTRONIC CRDM THERAPY DELIVERY PRODUCTS.
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