CAPSURE LEAD
FDA premarket approval P830061/S106 · decided 2014-02-04
Approval details
- PMA number
- P830061
- Supplement
- S106
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CAPSURE LEAD
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2014-01-22
- Decision date
- 2014-02-04
- Days to decision
- 13 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- ALTERNATE MANUFACTURING FACILITY OF EXISTING SUPPLIER, AND UTILIZATION OF SUPPLIER QUALITY MANAGEMENT (SQM) AS THE INCOMING INSPECTION CONTROL FOR THERMOFORMED BLISTER TRAYS.
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