CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM
FDA premarket approval P960040/S229 · decided 2010-09-02
Approval details
- PMA number
- P960040
- Supplement
- S229
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2010-08-06
- Decision date
- 2010-09-02
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- CHANGE TO THE SUPPLIED PIN LENGTH AND WELDING PROCESS USED IN THE ANODE ASSEMBLY MANUFACTURING PROCESS.
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