PMA P910073S149
- Device
- Endotak Reliance IS-1 Lead Family, Endotak Reliance IS4 Lead Family, Reliance 4-Front Lead Family
- Applicant
- Boston Scientific
- PMA number
- P910073
- Supplement
- S149
- Product code
- LWS
- Decision date
- 2018-05-16
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Add alternate drug identifying equipment.
Current openFDA PMA Record#
- Device
- Endotak Reliance IS-1 Lead Family, Endotak Reliance IS4 Lead Family, Reliance 4-Front Lead Family
- Applicant
- Boston Scientific
- PMA number
- P910073
- Supplement
- S149
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2018-05-16
- Decision code
- OK30
- Date received
- 2018-04-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add alternate drug identifying equipment.