FDA PMA
FDA Class 3
Approved
🇺🇸 United States
System, Esophageal Pacing
PMA: P860008
·
Supplement: S009
·
Decision Mar 25, 1991
Classifications
1
FEI Numbers
1
Registration Numbers
1
Basic Information
- Device Name
- System, Esophageal Pacing
- Trade Name
- ESOPHAGEAL CARDIAC RECORDING & PACING CATHETER
- PMA Number
- P860008
- Supplement Number
- S009
- 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
- March 25, 1991
- Date Received
- April 12, 1990
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
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 |