FDA PMA
FDA Class 3
Approved
🇺🇸 United States
System, Esophageal Pacing
PMA: P860008
·
Decision Dec 30, 1986
Classifications
1
FEI Numbers
1
Registration Numbers
1
Basic Information
- Device Name
- System, Esophageal Pacing
- Trade Name
- ARZCO TRANSESOPHAGEAL CARDIAC STIMULATOR MODEL 7
- PMA Number
- P860008
- Device Class
- FDA Class 3
- Product Code
- LPA
- Generic Name
- SYSTEM, ESOPHAGEAL PACING
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- December 30, 1986
- Date Received
- March 17, 1986
- Expedited Review
- N
- Docket Number
- 87M-0009
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 |
|---|---|---|---|
| LPA | System, Esophageal Pacing | FDA class 3 | Unknown |