PMA P960040S430
- Device
- PUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIGILANT, PERCIVA, RESONATE
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S430
- Product code
- LWS
- Decision date
- 2018-11-16
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Addition of alternative equipment to sterilize Accolade, NG3, NG4,and EMBLEM S-ICD product families using the new sterilization cycle DEV_PROD55_02 at the Clonmel, Ireland manufacturing facility.
Current openFDA PMA Record#
- Device
- PUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIGILANT, PERCIVA, RESONATE
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S430
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2018-11-16
- Decision code
- OK30
- Date received
- 2018-10-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of alternative equipment to sterilize Accolade, NG3, NG4,and EMBLEM S-ICD product families using the new sterilization cycle DEV_PROD55_02 at the Clonmel, Ireland manufacturing facility.