PMA P910077S179
- Device
- LATITUDE Wave Communicators
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S179
- Product code
- LWS
- Decision date
- 2020-06-12
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Alternate, functionally equivalent manufacturing line for LATITUDE Wave Communicator printed circuit assemblies.
Current openFDA PMA Record#
- Device
- LATITUDE Wave Communicators
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S179
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2020-06-12
- Decision code
- OK30
- Date received
- 2020-05-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate, functionally equivalent manufacturing line for LATITUDE Wave Communicator printed circuit assemblies.