PMA P960040S404
- Device
- ICDs: PUNCTUA, ENERGEN, INCEPTA
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S404
- Product code
- LWS
- Decision date
- 2017-10-11
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Modifications to the manufacturing process for the spring contact housing components.
Current openFDA PMA Record#
- Device
- ICDs: PUNCTUA, ENERGEN, INCEPTA
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S404
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2017-10-11
- Decision code
- OK30
- Date received
- 2017-09-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the manufacturing process for the spring contact housing components.