FDA PMA
FDA Class 3
Approved (Withdrawn)
🇺🇸 United States
Sealant, Polymerizing
PMA: P990028
·
Decision May 26, 2000
Classifications
1
FEI Numbers
15
Registration Numbers
15
Basic Information
- Device Name
- Sealant, Polymerizing
- Trade Name
- FOCAL SEAL-L SYNTHETIC ABSORBABLE SEALANT
- PMA Number
- P990028
- Device Class
- FDA Class 3
- Product Code
- NBE
- Generic Name
- Sealant, polymerizing
- Medical Specialty
- Unknown
- Advisory Committee
- General, Plastic Surgery
- Decision
- Approved (Withdrawn)
- Decision Code
- APWD
- Decision Date
- May 26, 2000
- Date Received
- June 7, 1999
- Expedited Review
- N
- Docket Number
- 00M-1507
Advisory Committee Statement
APPROVAL FOR THE FOCALSEAL-L SYNTHETIC ABSORBABLE SEALANT.
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 |
|---|---|---|---|
| NBE | Sealant, Polymerizing | FDA class 3 | Unknown |