PMA P110042S079
- Device
- Emblem S-ICD Programmer - Plexus SMT Mfg. Line
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S079
- Product code
- LWS
- Decision date
- 2017-03-21
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- New manufacturing line for the programmer radio board printed circuit board assembly for the Model 3200 EMBLEM Programmer.
Current openFDA PMA Record#
- Device
- Emblem S-ICD Programmer - Plexus SMT Mfg. Line
- Applicant
- Boston Scientific Corporation
- PMA number
- P110042
- Supplement
- S079
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2017-03-21
- Decision code
- OK30
- Date received
- 2017-02-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New manufacturing line for the programmer radio board printed circuit board assembly for the Model 3200 EMBLEM Programmer.