ADHESIVE/CAPSURE SENSE/CAPSURE SP NOVUS/VITATRON CRYSTALLINE/VITATRON EXCELLENCE PS+ LEADS
FDA premarket approval P830061/S136 · decided 2016-11-02
Approval details
- PMA number
- P830061
- Supplement
- S136
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ADHESIVE/CAPSURE SENSE/CAPSURE SP NOVUS/VITATRON CRYSTALLINE/VITATRON EXCELLENCE PS+ LEADS
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2016-10-05
- Decision date
- 2016-11-02
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Endotoxin test method changes for leads and accessories.
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