FDA PMA
FDA Class 3
Approved (Withdrawn)
🇺🇸 United States
Catheter, Balloon For Retinal Reattachment
PMA: P820009
·
Decision Oct 25, 1983
Classifications
1
FEI Numbers
0
Registration Numbers
0
Basic Information
- Device Name
- Catheter, Balloon For Retinal Reattachment
- Trade Name
- LINCOFF-DESIGN SCLERAL BUCKLING BALLOON CATHETER
- PMA Number
- P820009
- Device Class
- FDA Class 3
- Product Code
- LOG
- Generic Name
- Catheter, balloon for retinal reattachment
- Medical Specialty
- Unknown
- Advisory Committee
- Ophthalmic
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- October 25, 1983
- Date Received
- February 22, 1982
- Expedited Review
- N
- Docket Number
- 83M-0370
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 |
|---|---|---|---|
| LOG | Catheter, Balloon For Retinal Reattachment | FDA class 3 | Unknown |