PMA P830060S044
- Device
- SWEET TIP
- Applicant
- Boston Scientific
- PMA number
- P830060
- Supplement
- S044
- Product code
- LWS
- Decision date
- 1998-12-08
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval for use of a larger diameter wire helix in the lead's tip electrode, and associated labeling changes.
Current openFDA PMA Record#
- Device
- SWEET TIP
- Applicant
- Boston Scientific
- PMA number
- P830060
- Supplement
- S044
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 1998-12-08
- Decision code
- APPR
- Date received
- 1998-11-20
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for use of a larger diameter wire helix in the lead's tip electrode, and associated labeling changes.