PMA P910073S142
- Device
- ENDOTAK RELIANCE™, (Defibrillation Leads)
- Applicant
- Boston Scientific
- PMA number
- P910073
- Supplement
- S142
- Product code
- LWS
- Decision date
- 2017-09-20
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval to label a subset of the market released devices as ImageReady MR Conditional Defibrillation System.
Current openFDA PMA Record#
- Device
- ENDOTAK RELIANCE™, (Defibrillation Leads)
- Applicant
- Boston Scientific
- PMA number
- P910073
- Supplement
- S142
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2017-09-20
- Decision code
- APPR
- Date received
- 2017-05-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval to label a subset of the market released devices as ImageReady MR Conditional Defibrillation System.