CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD,CAPSURE Z NOVUS LEAD, VITATRON IMPULSE II LEAD
FDA premarket approval P850089/S109 · decided 2014-08-20
Approval details
- PMA number
- P850089
- Supplement
- S109
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD,CAPSURE Z NOVUS LEAD, VITATRON IMPULSE II LEAD
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2014-07-24
- Decision date
- 2014-08-20
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- REPLACEMENT OF A MANUAL RECORDING SYSTEM FOR MONITORING DIFFERENTIALPRESSURE WITH AN AUTOMATED SYSTEM.
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