MICRONY FAMILY OF PACEMAKERS
FDA premarket approval P970013/S033 · decided 2010-06-18
Approval details
- PMA number
- P970013
- Supplement
- S033
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MICRONY FAMILY OF PACEMAKERS
- Generic name
- Pulse-generator, single chamber, sensor driven, implantable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2010-05-21
- Decision date
- 2010-06-18
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWO
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- ALTERNATE METHOD OF BIOBURDEN TESTING.
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