PMA P830060S046
- Device
- VENTAK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P830060
- Supplement
- S046
- Product code
- LWS
- Decision date
- 2000-03-10
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval for the use of a modified suture sleeve.
Current openFDA PMA Record#
- Device
- VENTAK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P830060
- Supplement
- S046
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2000-03-10
- Decision code
- APPR
- Date received
- 1999-12-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the use of a modified suture sleeve.