PMA P960040S405
- Device
- SMART-MSP
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S405
- Product code
- LWS
- Decision date
- 2017-11-17
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- SMART-MSP
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S405
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2017-11-17
- Decision code
- APPR
- Date received
- 2017-09-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.