CAPSURE SP NOVUS LEAD; CAPSURE SP Z LEAD, CAPSURE Z NOVUS LEAD, VITATRON IMPULSE II LEAD.
FDA premarket approval P850089/S116 · decided 2016-01-25
Approval details
- PMA number
- P850089
- Supplement
- S116
- 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
- 2015-12-28
- Decision date
- 2016-01-25
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- IMPLEMENTATION OF SELECT FINAL REPACKAGING MANUFACTURING ACTIVITIES AT MEDTRONIC'S MEMPHIS DISTRIBUTION CENTER IN MEMPHIS, TENNESSEE FOR THE DEVICES.
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