PMA P910073S153
- Device
- Reliance 4-Front, 4-Site IS-1 Defibrillation
- Applicant
- Boston Scientific
- PMA number
- P910073
- Supplement
- S153
- Product code
- LWS
- Decision date
- 2019-02-28
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval for sales packaging and label changes.
Current openFDA PMA Record#
- Device
- Reliance 4-Front, 4-Site IS-1 Defibrillation
- Applicant
- Boston Scientific
- PMA number
- P910073
- Supplement
- S153
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2019-02-28
- Decision code
- APPR
- Date received
- 2018-12-26
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for sales packaging and label changes.