Microny Pacemaker
FDA premarket approval P970013/S080 · decided 2018-12-11
Approval details
- PMA number
- P970013
- Supplement
- S080
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Microny Pacemaker
- Generic name
- Pulse-generator, single chamber, sensor driven, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2018-11-20
- Decision date
- 2018-12-11
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- LWO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Add Stereo as an alternate supplier of 100% ethylene oxide gas.
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