PMA P910077S105
- Device
- IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S105
- Product code
- LWS
- Decision date
- 2010-07-22
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- CHANGE IN THE BOND LINE THICKNESS AND LEAD FRAME PLATING FOR THE DIGITAL POTENTIOMETER.
Current openFDA PMA Record#
- Device
- IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S105
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2010-07-22
- Decision code
- OK30
- Date received
- 2010-06-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE BOND LINE THICKNESS AND LEAD FRAME PLATING FOR THE DIGITAL POTENTIOMETER.