PMA P910077S016
- Device
- ABBOTT IMX SA
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S016
- Product code
- LWS
- Decision date
- 1996-11-18
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR MODEL 2840, SOFTWARE APPLICATION, VERSION 2.2 WHICH IS A MODIFICATION OF VERSION 2.1
Current openFDA PMA Record#
- Device
- ABBOTT IMX SA
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S016
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 1996-11-18
- Decision code
- APPR
- Date received
- 1996-07-09
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODEL 2840, SOFTWARE APPLICATION, VERSION 2.2 WHICH IS A MODIFICATION OF VERSION 2.1