CAPSURE Z NOVUS LEADS, CAPSURE Z LEADS, CAPSURE SP LEADS AND CAPSURE SP NOVUS LEADS
FDA premarket approval P850089/S062 · decided 2010-01-21
Approval details
- PMA number
- P850089
- Supplement
- S062
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CAPSURE Z NOVUS LEADS, CAPSURE Z LEADS, CAPSURE SP LEADS AND CAPSURE SP NOVUS LEADS
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2009-10-08
- Decision date
- 2010-01-21
- Days to decision
- 105 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR REFORMULATION OF THE HOTMELT ADHESIVE THAT IS USED IN MEDTRONIC CRDM STERILE BARRIER PACKAGES.
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