FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Catheter, Percutaneous, Long Term, Intraspinal
PMA: P860064
·
Supplement: S005
·
Decision Oct 19, 1990
Classifications
1
FEI Numbers
1
Registration Numbers
1
Basic Information
- Device Name
- Catheter, Percutaneous, Long Term, Intraspinal
- Trade Name
- DAVOL EXTERNALIZED EPIDURAL CATHETER
- PMA Number
- P860064
- Supplement Number
- S005
- Device Class
- FDA Class 3
- Product Code
- LNY
- Generic Name
- CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
- Medical Specialty
- Unknown
- Advisory Committee
- General Hospital
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- October 19, 1990
- Date Received
- September 7, 1990
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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 |
|---|---|---|---|
| LNY | Catheter, Percutaneous, Long Term, Intraspinal | FDA class 3 | Unknown |