PMA P910077S190
- Device
- LATITUDE Wave Communicator Model 6290
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S190
- Product code
- LWS
- Decision date
- 2022-12-14
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Add an equivalent manufacturing line used for printed circuit assemblies for the LATITUDE Wave Communicator Model 6290.
Current openFDA PMA Record#
- Device
- LATITUDE Wave Communicator Model 6290
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S190
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2022-12-14
- Decision code
- OK30
- Date received
- 2022-11-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add an equivalent manufacturing line used for printed circuit assemblies for the LATITUDE Wave Communicator Model 6290.