PMA P000052S016
- Device
- GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM
- Applicant
- Guidant Corp.
- PMA number
- P000052
- Supplement
- S016
- Product code
- MOU
- Decision date
- 2003-06-27
- Classification
- Cardiovascular
- Generic name
- Intravascular radiation delivery system
- Approval order statement
- APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY FOR THE SOURCE BLANK SUBASSEMBLY. THE FACILITY IS LOCATED AT GUIDANT CORPORATION, HOUSTON, TEXAS.
Current openFDA PMA Record#
- Device
- GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM
- Applicant
- Guidant Corp.
- PMA number
- P000052
- Supplement
- S016
- Product code
- MOU
- Generic name
- Intravascular radiation delivery system
- Decision date
- 2003-06-27
- Decision code
- APPR
- Date received
- 2003-01-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Approval order statement
- APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY FOR THE SOURCE BLANK SUBASSEMBLY. THE FACILITY IS LOCATED AT GUIDANT CORPORATION, HOUSTON, TEXAS.