CAPSURE SENSE & SP NOVUS
FDA premarket approval P830061/S040 · decided 2009-10-30
Approval details
- PMA number
- P830061
- Supplement
- S040
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CAPSURE SENSE & SP NOVUS
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2008-03-10
- Decision date
- 2009-10-30
- Days to decision
- 599 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR TRANSFER OF A MANUFACTURING LOCATION FOR A COMPONENT OF THE LEADS.
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