PMA P910077S043
- Device
- VENTAK MINI I, II,III
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S043
- Product code
- LWS
- Decision date
- 2003-12-24
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR LABELING CHANGES TO UPDATE BATTERY LONGEVITY INFORMATION.
Current openFDA PMA Record#
- Device
- VENTAK MINI I, II,III
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S043
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2003-12-24
- Decision code
- APPR
- Date received
- 2003-11-26
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABELING CHANGES TO UPDATE BATTERY LONGEVITY INFORMATION.