RELIANCE ACTIVE FIX, & PASSIVE FIX STEROID ELUTING ENDOCARDIAL DEFIBRILLATION LEAD
FDA premarket approval P910073/S057 · decided 2005-11-22
Approval details
- PMA number
- P910073
- Supplement
- S057
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RELIANCE ACTIVE FIX, & PASSIVE FIX STEROID ELUTING ENDOCARDIAL DEFIBRILLATION LEAD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2005-10-24
- Decision date
- 2005-11-22
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- ADDITION OF SIGHT HOLES TO THE TERMINAL PINS, WITH INCREASE IN INSERTION CAVITY FOR THE PASSIVE FIX VERSION, RESULTING IN AN ADDITIONAL INSPECTION STEP.
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