CapSureFix Novus Lead, Vitatron Crystalline Active Fixation/Pirouet Lead
FDA premarket approval P930039/S174 · decided 2017-07-05
Approval details
- PMA number
- P930039
- Supplement
- S174
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CapSureFix Novus Lead, Vitatron Crystalline Active Fixation/Pirouet Lead
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Medtronic, Inc.
- Date received
- 2017-06-28
- Decision date
- 2017-07-05
- Days to decision
- 7 days
- Decision code
- OK30
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Removal of the use of clean benches from the Heart Failure and Low Voltage manufacturing areas at Medtronic Puerto Rico Operations Company in Villalba, Puerto Rico.
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