MICRONY CRT-P'S
FDA premarket approval P970013/S059 · decided 2014-06-25
Approval details
- PMA number
- P970013
- Supplement
- S059
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MICRONY CRT-P'S
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2014-05-28
- Decision date
- 2014-06-25
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- ADD AN ALTERNATE SUPPLIER FOR THE IDENTICAL EPOXY USED IN THE MANUFACTURE OF THE DEVICES.
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