FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
PMA: P830061
·
Decision Jul 29, 1986
Classifications
1
FEI Numbers
26
Registration Numbers
26
Basic Information
- Device Name
- Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
- Trade Name
- STEROID TIP(TM) MODEL 4503&4003 TRANSVENOUS PACING
- PMA Number
- P830061
- Device Class
- FDA Class 3
- Product Code
- NVN
- Generic Name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- July 29, 1986
- Date Received
- October 3, 1983
- Expedited Review
- N
- Docket Number
- 86M-0330
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NVN | Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes | FDA class 3 | Unknown |