GUIDANT PULSE GENERATORS
FDA premarket approval P830060/S058 · decided 2005-06-20
Approval details
- PMA number
- P830060
- Supplement
- S058
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- GUIDANT PULSE GENERATORS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2005-05-27
- Decision date
- 2005-06-20
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR ADDITIONAL INSTRUCTION FOR USE FOR FREEING STUCK SETSCREWS USING THE BI-DIRECTIONAL TORQUE WRENCH.
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