Merlin Patient Care System Programmer
FDA premarket approval P030054/S327 · decided 2017-10-20
Approval details
- PMA number
- P030054
- Supplement
- S327
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Merlin Patient Care System Programmer
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2017-04-03
- Decision date
- 2017-10-20
- Days to decision
- 200 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for the accessory Bluetooth dongle, Model BLU1000, to be used with the Merlin Patient Care System (PCS) Model 3650 programmer.
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