MEDTRONIC SELECTSECURE LEAD/ANCHORING SLEEVE KIT
FDA premarket approval P030036/S089 · decided 2016-12-14
Approval details
- PMA number
- P030036
- Supplement
- S089
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC SELECTSECURE LEAD/ANCHORING SLEEVE KIT
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2016-11-14
- Decision date
- 2016-12-14
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Implementation of an update to FACTORYworks (FW) Release 9.3.
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