PMA P960040S426
- Device
- MANAGE HF Study
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S426
- Product code
- LWS
- Decision date
- 2018-08-21
- 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
- MANAGE HF Study
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S426
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2018-08-21
- Decision code
- APPR
- Date received
- 2018-06-22
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.