ICD Devices
FDA premarket approval P960040/S483 · decided 2022-12-20
Approval details
- PMA number
- P960040
- Supplement
- S483
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ICD Devices
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2022-09-29
- Decision date
- 2022-12-20
- Days to decision
- 82 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for hardware and software changes to the LATITUDE NXT Patient Management System Communicator (Models 6280/6498 and 6290) required for the removal of the telephone modem (POTS plain old telephone service).
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