PMA P960040S402
- Device
- ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIGILANT, PERCIVA, RESONATE; Implantable Cardioverter Defibrillator(ICD)
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S402
- Product code
- LWS
- Decision date
- 2017-09-28
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Addition of an alternate supplier of the titanium raw material.
Current openFDA PMA Record#
- Device
- ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIGILANT, PERCIVA, RESONATE; Implantable Cardioverter Defibrillator(ICD)
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S402
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2017-09-28
- Decision code
- OK30
- Date received
- 2017-08-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternate supplier of the titanium raw material.