ANTHEM RF CRT-PS
FDA premarket approval P030035/S112 · decided 2013-09-05
Approval details
- PMA number
- P030035
- Supplement
- S112
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ANTHEM RF CRT-PS
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2013-08-06
- Decision date
- 2013-09-05
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- CHANGE IN THE ENCAPSULATION CURE PROCESS FOR THE LEFT VENTRICULAR RADIOFREQUENCY (LV RF) MODULES IN THE DEVICES.
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