COROX OTW 75-UP STEROID LEAD, COROS OTW 85-UP STEROID LEAD
FDA premarket approval P050023/S056 · decided 2013-01-11
Approval details
- PMA number
- P050023
- Supplement
- S056
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- COROX OTW 75-UP STEROID LEAD, COROS OTW 85-UP STEROID LEAD
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Applicant
- Biotronik, Inc.
- Date received
- 2012-10-12
- Decision date
- 2013-01-11
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- OJX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR UPDATING THE LABELING FOR THE COROX FAMILY OVER THE WIRE (OTW) LEFT VENTRICULAR (LV) PACING LEAD TO REFLECT THE FINDINGS OF THE COROX OTW STEROID LV MONITORING (COSMO) POST-APPROVAL STUDY.
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510(k) clearances by this applicant
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|---|---|---|
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| Oscar Peripheral Multifunctional Catheter system (K241711) | Biotronik, Inc. | 2024-07-11 |
| BIOMONITOR IV (K230375) | Biotronik, Inc. | 2023-05-19 |
| Passeo-35 Xeo Peripheral Dilatation Catheter (K222065) | Biotronik, Inc. | 2023-02-16 |
| BIOMONITOR IIIm, BIOMONITOR III (K221856) | Biotronik, Inc. | 2022-07-27 |