PMA P910073S154
- Device
- LV Lead Quadpole Connector IS4, Accessory Kit Lead Cap, Accessory Stylet TAPER FIX SOFT 64CM, 70CM, and 100CM, Accessory
- Applicant
- Boston Scientific
- PMA number
- P910073
- Supplement
- S154
- Product code
- LWS
- Decision date
- 2019-04-08
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Modifications to the frequency, equipment and method for monitoring airborne particulates.
Current openFDA PMA Record#
- Device
- LV Lead Quadpole Connector IS4, Accessory Kit Lead Cap, Accessory Stylet TAPER FIX SOFT 64CM, 70CM, and 100CM, Accessory
- Applicant
- Boston Scientific
- PMA number
- P910073
- Supplement
- S154
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2019-04-08
- Decision code
- OK30
- Date received
- 2019-03-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the frequency, equipment and method for monitoring airborne particulates.