CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM
FDA premarket approval P960040/S227 · decided 2011-04-08
Approval details
- PMA number
- P960040
- Supplement
- S227
- Supplement type
- 135 Review Track For 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
- 2010-08-05
- Decision date
- 2011-04-08
- Days to decision
- 246 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE ADDITION OF A RECEIVING INSPECTION STEP FOR SETSCREWS ON HEADER COMPONENTS.
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