PMA P830060S070
- Device
- VENTAK AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM FAMILY
- Applicant
- Boston Scientific
- PMA number
- P830060
- Supplement
- S070
- Product code
- LWS
- Decision date
- 2012-04-23
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- IMPLEMENTATION OF A NEW ACCEPTANCE METHODOLOGY AT THE QUALITY SYSTEM LEVEL.
Current openFDA PMA Record#
- Device
- VENTAK AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (AICD) SYSTEM FAMILY
- Applicant
- Boston Scientific
- PMA number
- P830060
- Supplement
- S070
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2012-04-23
- Decision code
- OK30
- Date received
- 2012-03-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IMPLEMENTATION OF A NEW ACCEPTANCE METHODOLOGY AT THE QUALITY SYSTEM LEVEL.