PMA P910073S148
- Device
- Endotak Lead System
- Applicant
- Boston Scientific
- PMA number
- P910073
- Supplement
- S148
- Product code
- LWS
- Decision date
- 2018-04-25
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Updates to the BET test method.
Current openFDA PMA Record#
- Device
- Endotak Lead System
- Applicant
- Boston Scientific
- PMA number
- P910073
- Supplement
- S148
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2018-04-25
- Decision code
- OK30
- Date received
- 2018-03-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Updates to the BET test method.