PMA P910073S167
- Device
- Endoktak Lead System
- Applicant
- Boston Scientific
- PMA number
- P910073
- Supplement
- S167
- Product code
- LWS
- Decision date
- 2021-10-06
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Add an alternate thermal transfer ribbon for improved legibility for use in the Dorado, Puerto Rico facility.
Current openFDA PMA Record#
- Device
- Endoktak Lead System
- Applicant
- Boston Scientific
- PMA number
- P910073
- Supplement
- S167
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2021-10-06
- Decision code
- OK30
- Date received
- 2021-09-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an alternate thermal transfer ribbon for improved legibility for use in the Dorado, Puerto Rico facility.