Microny family of Pacemakers
FDA premarket approval P970013/S092 · decided 2023-04-14
Approval details
- PMA number
- P970013
- Supplement
- S092
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Microny family of Pacemakers
- Generic name
- Pulse-generator, single chamber, sensor driven, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2023-02-01
- Decision date
- 2023-04-14
- Days to decision
- 72 days
- Decision code
- APPR
- Product code
- LWO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for software changes in the Merlin PCS Model 3330 Software v27.0.1 and Merlint.net MN5000 v8.0.
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| Assert-IQ (DM5100) (K253516) | ABBOTT MEDICAL | 2025-12-18 |