PMA P010012S030
- Device
- FINISHING WIRE UNIVERSAL , MODEL NUMBERS 6002,6003,6004,6005,6007
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S030
- Product code
- NIK
- Decision date
- 2004-07-21
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- APPROVAL FOR ADDING INSTRUCTIONS IN THE LABELING TO CONTINUE FLUOROSCOPY DURING REMOVAL OF THE GUIDING CATHETER.
Current openFDA PMA Record#
- Device
- FINISHING WIRE UNIVERSAL , MODEL NUMBERS 6002,6003,6004,6005,6007
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S030
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2004-07-21
- Decision code
- APPR
- Date received
- 2004-06-25
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR ADDING INSTRUCTIONS IN THE LABELING TO CONTINUE FLUOROSCOPY DURING REMOVAL OF THE GUIDING CATHETER.