LATITUDE Wave Communicator Model 6290
FDA premarket approval P910077/S190 · decided 2022-12-14
Approval details
- PMA number
- P910077
- Supplement
- S190
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LATITUDE Wave Communicator Model 6290
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2022-11-16
- Decision date
- 2022-12-14
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Add an equivalent manufacturing line used for printed circuit assemblies for the LATITUDE Wave Communicator Model 6290.
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