PMA P910077S035
- Device
- VENTAK MINI IV (AICD)
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S035
- Product code
- LWS
- Decision date
- 2000-12-06
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR THE MODIFICATION OF THE MINI(TM) IV AICD(TM) HEADER AND REMOVING THE STERILE MINERAL OIL AND HEX WRENCH FROM THE PACKAGE.
Current openFDA PMA Record#
- Device
- VENTAK MINI IV (AICD)
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S035
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2000-12-06
- Decision code
- APPR
- Date received
- 2000-11-07
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE MODIFICATION OF THE MINI(TM) IV AICD(TM) HEADER AND REMOVING THE STERILE MINERAL OIL AND HEX WRENCH FROM THE PACKAGE.