CAPSURE Z/NOVUS LEADS/ CAPSURE SP/NOVUS LEADS/EXCELLENCE S+/IMPULSE/VITATRON IMPULSE II
FDA premarket approval P850089/S064 · decided 2010-02-18
Approval details
- PMA number
- P850089
- Supplement
- S064
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CAPSURE Z/NOVUS LEADS/ CAPSURE SP/NOVUS LEADS/EXCELLENCE S+/IMPULSE/VITATRON IMPULSE II
- Generic name
- Permanent defibrillator electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2010-01-19
- Decision date
- 2010-02-18
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- TRANSFER OF MEDTRONIC¿S RICE CREEK SILICONE MOLDING OPERATIONS.
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