STEROID TIP(TM) MODEL 4503&4003 TRANSVENOUS PACING
FDA premarket approval P830061/S173 · decided 2020-04-23
Approval details
- PMA number
- P830061
- Supplement
- S173
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STEROID TIP(TM) MODEL 4503&4003 TRANSVENOUS PACING
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2019-07-01
- Decision date
- 2020-04-23
- Days to decision
- 297 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for Cobalt XT, Cobalt, and Crome MRI SureScan Implantable Cardioverter Defibrillator (ICD) and ICD with Cardiac Resynchronization Systems.
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