FDA PMA
Approved
🇺🇸 United States
PMA: P980035
·
Supplement: S007
·
Decision May 11, 2000
Classifications
0
FEI Numbers
0
Registration Numbers
0
Basic Information
- Trade Name
- KAPPA 706 SR IPG
- PMA Number
- P980035
- Supplement Number
- S007
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- May 11, 2000
- Date Received
- April 10, 2000
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for a modification to header part number 149422 for use with the Kappa SR Model 706.